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Guidelines updated for treating community-acquired pneumonia
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
“Ever since we wrote the first CAP [community-acquired pneumonia] guidelines in 1993, we’ve heard good and bad things, and I agree with both,” Michael S. Niederman, MD, FCCP, said in a presentation at IDWeek 2019. “For good or for bad, [guidelines] are a standard against which care can be evaluated.” He discussed how, as guidelines have become more evidence based, they have often become “more wishy washy,” that when the evidence is weak, the recommendation is weak, and the guidelines merely advise doctors: “You figure it out.”
However, he pointed out that, since CAP guidelines were developed, there have been overall improvements in patient care and antibiotic stewardship. But he saw several weaknesses in the new guidelines, including the fact that they did not update minor criteria for determining severe CAP from the 2007 guidelines, despite several studies indicating that there were other criteria to consider. In addition, the updated guidelines held a negative view of the use of serum procalcitonin to guide site-of-care decisions, which Dr. Niederman argued went against an analysis of the Etiology of Pneumonia in the Community (EPIC) study (CHEST. 2016; 150[4]:819-28) and other studies that showed its utility. He referred to his own editorial, in which he discussed the subject extensively (Lancet Resp Med. 2016;4[12]:956).
“Similarly, to me, the macrolide issue is not resolved,” he added, citing several studies that, in contrast to the guideline recommendations, used outpatient macrolide monotherapy to good results, and one study showed that “there was a much better patient outcome for patients who got macrolide monotherapy than for those who got quinolones” (Resp Med. 2012;106[3]:451-8).
Dr. Niederman is clinical director of the division of pulmonary and critical care medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, and professor of clinical medicine at Weill Cornell Medical College, New York. He disclosed that he is a consultant for and has received grants from a variety of pharmaceutical companies, including Bayer and Merck.
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
An update to the 2007 guidelines on the treatment of community-acquired pneumonia (CAP) was published by two medical societies, based upon the work of a multidisciplinary panel that “conducted pragmatic systematic reviews of the relevant research and applied Grading of Recommendations, Assessment, Development, and Evaluation methodology for clinical recommendations.”
The panel addressed 16 questions in the areas including diagnostic testing, determination of site of care, selection of initial empiric antibiotic therapy, and subsequent management decisions. Some of their recommendations remained unchanged from the 2007 guideline, but others were updated based upon more-recent clinical trials and epidemiological studies, according to Joshua P. Metlay, MD, of Massachusetts General Hospital, Boston, and colleagues on behalf of the Infectious Diseases Society of America and the American Thoracic Society.
Among the key recommendations differing from the previous guidelines, the 2019 guidelines include the following:
- Sputum and blood culture samples are recommended in patients with severe disease, as well as in all inpatients empirically treated for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
- Macrolide monotherapy is only conditionally recommended for outpatients based on resistance levels.
- Procalcitonin assessment, not covered in the 2007 guidelines, is not recommended in order to determine initial antibiotic therapy.
- Corticosteroid use, not covered in the 2007 guidelines, is not recommended, though it may be considered in patients with refractory septic shock.
- The use of health care–associated pneumonia (HCAP) as a category should be dropped, with a switch to an emphasis on local epidemiology and validated risk factors to determine the need for MRSA or P. aeruginosa treatment.
- Standard empiric therapy for severe CAP should be beta-lactam/macrolide and beta-lactam/fluoroquinolone combinations, but with stronger evidence in favor of the beta-lactam/macrolide combination.
The updated guidelines also include a number of other recommendations, such as those dealing with the management of patients with comorbidities, and were published in the American Journal of Respiratory and Critical Care Medicine.
“A difference between this guideline and previous ones is that we have significantly increased the proportion of patients in whom we recommend routinely obtaining respiratory tract samples for microbiologic studies. This decision is largely based on a desire to correct the overuse of anti-MRSA and antipseudomonal therapy that has occurred since the introduction of the HCAP classification (which we recommend abandoning) rather than high-quality evidence,” the authors stated in their conclusions. They added that they “expect our move against endorsing monotherapy with macrolides, which is based on population resistance data rather than high-quality clinical studies, will generate future outcomes studies comparing different treatment strategies.”
Many of the authors reported relationships with a variety of pharmaceutical companies; full disclosures are detailed at the end of the guideline publication.
SOURCE: Metlay JP et al. Am J Respir Crit Med. 2019;200(7):e45-67.
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
FDA gives nod to earlier use of Nplate in adults with ITP
Romiplostim (Nplate) earned a new indication from the Food and Drug Administration, allowing for earlier usage in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
The new indication is for newly diagnosed and persistent adult patients.
Romiplostim is already approved for the treatment of pediatric patients aged 1 year and older who have had ITP for at least 6 months and had an insufficient response to other treatments, as well as for adults patients with chronic ITP who had insufficient response to other therapies.
The latest approval is based on positive results from a single-arm, phase 2 trial in adults with ITP who had an insufficient response to first-line treatment. The study met its primary endpoint – platelet response (50 x 109/L or greater). The median number of months with platelet response was 11 months during a 12-month treatment period. The median time to first platelet response was just over 2 weeks.
Adverse events of at least 5% incidence in patients taking romiplostim with an ITP duration up to 12 months included bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea, and oropharyngeal pain. There was a 2% incidence of thrombocytosis among adults with an ITP duration up to 12 months.
Romiplostim (Nplate) earned a new indication from the Food and Drug Administration, allowing for earlier usage in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
The new indication is for newly diagnosed and persistent adult patients.
Romiplostim is already approved for the treatment of pediatric patients aged 1 year and older who have had ITP for at least 6 months and had an insufficient response to other treatments, as well as for adults patients with chronic ITP who had insufficient response to other therapies.
The latest approval is based on positive results from a single-arm, phase 2 trial in adults with ITP who had an insufficient response to first-line treatment. The study met its primary endpoint – platelet response (50 x 109/L or greater). The median number of months with platelet response was 11 months during a 12-month treatment period. The median time to first platelet response was just over 2 weeks.
Adverse events of at least 5% incidence in patients taking romiplostim with an ITP duration up to 12 months included bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea, and oropharyngeal pain. There was a 2% incidence of thrombocytosis among adults with an ITP duration up to 12 months.
Romiplostim (Nplate) earned a new indication from the Food and Drug Administration, allowing for earlier usage in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
The new indication is for newly diagnosed and persistent adult patients.
Romiplostim is already approved for the treatment of pediatric patients aged 1 year and older who have had ITP for at least 6 months and had an insufficient response to other treatments, as well as for adults patients with chronic ITP who had insufficient response to other therapies.
The latest approval is based on positive results from a single-arm, phase 2 trial in adults with ITP who had an insufficient response to first-line treatment. The study met its primary endpoint – platelet response (50 x 109/L or greater). The median number of months with platelet response was 11 months during a 12-month treatment period. The median time to first platelet response was just over 2 weeks.
Adverse events of at least 5% incidence in patients taking romiplostim with an ITP duration up to 12 months included bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea, and oropharyngeal pain. There was a 2% incidence of thrombocytosis among adults with an ITP duration up to 12 months.
Vaping-linked lung injuries near 1,500
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
Vaccination rates generally high in U.S. children in 2018
Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.
The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.
By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.
A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.
The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.
“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.
In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.
The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.
In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).
“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.
No conflicts of interest were reported by the investigators of either study.
SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.
Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.
The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.
By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.
A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.
The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.
“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.
In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.
The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.
In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).
“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.
No conflicts of interest were reported by the investigators of either study.
SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.
Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.
The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.
By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.
A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.
The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.
“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.
In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.
The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.
In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).
“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.
No conflicts of interest were reported by the investigators of either study.
SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.
FROM THE MMWR
FDA approves transdermal asenapine system for schizophrenia
The Food and Drug Administration has approved a transdermal asenapine delivery system (Secuado) for treatment of schizophrenia in adults, according to a release from Noven Pharmaceuticals.
The patch formulation is designed to deliver sustained concentrations of asenapine over 24-hour periods, so the system is a once-daily treatment. The efficacy and safety profile for children younger than 18 years is unknown.
The approval is based on an international, phase 3, double-blind, placebo-controlled study that included 616 adults with schizophrenia. The transdermal system achieved the study’s primary endpoint of statistically significant improvement at week 6 in the Positive and Negative Syndrome Scale, compared with placebo.
The safety profile of the system was consistent with the known profile of sublingual asenapine, and the most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain. The full prescribing information includes a boxed warning explaining that antipsychotics, such as asenapine, are associated with increased risk of death among elderly patients with dementia-related psychosis, an indication not approved for this transdermal asenapine-delivery system. Other warnings described in the prescribing information include neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes.
clinical professor of psychiatry and behavioral sciences at New York Medical College, in the release.
Noven is a subsidiary of Hisamitsu Pharmaceutical.
The Food and Drug Administration has approved a transdermal asenapine delivery system (Secuado) for treatment of schizophrenia in adults, according to a release from Noven Pharmaceuticals.
The patch formulation is designed to deliver sustained concentrations of asenapine over 24-hour periods, so the system is a once-daily treatment. The efficacy and safety profile for children younger than 18 years is unknown.
The approval is based on an international, phase 3, double-blind, placebo-controlled study that included 616 adults with schizophrenia. The transdermal system achieved the study’s primary endpoint of statistically significant improvement at week 6 in the Positive and Negative Syndrome Scale, compared with placebo.
The safety profile of the system was consistent with the known profile of sublingual asenapine, and the most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain. The full prescribing information includes a boxed warning explaining that antipsychotics, such as asenapine, are associated with increased risk of death among elderly patients with dementia-related psychosis, an indication not approved for this transdermal asenapine-delivery system. Other warnings described in the prescribing information include neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes.
clinical professor of psychiatry and behavioral sciences at New York Medical College, in the release.
Noven is a subsidiary of Hisamitsu Pharmaceutical.
The Food and Drug Administration has approved a transdermal asenapine delivery system (Secuado) for treatment of schizophrenia in adults, according to a release from Noven Pharmaceuticals.
The patch formulation is designed to deliver sustained concentrations of asenapine over 24-hour periods, so the system is a once-daily treatment. The efficacy and safety profile for children younger than 18 years is unknown.
The approval is based on an international, phase 3, double-blind, placebo-controlled study that included 616 adults with schizophrenia. The transdermal system achieved the study’s primary endpoint of statistically significant improvement at week 6 in the Positive and Negative Syndrome Scale, compared with placebo.
The safety profile of the system was consistent with the known profile of sublingual asenapine, and the most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain. The full prescribing information includes a boxed warning explaining that antipsychotics, such as asenapine, are associated with increased risk of death among elderly patients with dementia-related psychosis, an indication not approved for this transdermal asenapine-delivery system. Other warnings described in the prescribing information include neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes.
clinical professor of psychiatry and behavioral sciences at New York Medical College, in the release.
Noven is a subsidiary of Hisamitsu Pharmaceutical.
FDA approves rivaroxaban for VTE prevention in hospitalized, acutely ill patients
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
FDA approves Reyvow for acute migraine treatment
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
FDA approves afamelanotide for treatment of rare condition with light-induced pain
The Food and Drug Administration has approved , a rare condition that causes extremely painful reactions when skin is exposed to light, according to an FDA announcement.
This is the first treatment approved to help patients with this condition increase their exposure to light, according to the release.
Afamelanotide, administered in a subcutaneous implant, is a melanocortin-1 receptor (MC1-R) agonist, which “increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources,” the release says.
Approval is based on a pair of parallel-group clinical trials that compared the number of hours spent in sunlight in the treatment and placebo groups. The first trial enrolled 93 patients; 48 received afamelanotide. The treated patients spent a median of 61 hours in total over 180 days in direct sunlight between 10 a.m. and 6 p.m. on days with no pain, compared with 41 hours for patients taking placebo.
The second trial assessed the total number of hours over 270 days spent outdoors between 10 a.m. and 3 p.m. on days with no pain for which “most of the day” was spent in direct sunlight. In this study, 38 patients treated with afamelanotide spent a median total of 6 hours, compared with 0.75 hours among the remaining 36 who were taking a placebo.
The most common side effects include implant site reaction, nausea, and oropharyngeal pain. The implant should be administered only by trained professionals. Because afamelanotide may cause skin darkening, it’s recommended that patients should undergo twice-yearly skin examinations. Patients are also encouraged to maintain sun protection measures to help prevent phototoxic reactions.
“Today’s approval is one example of the FDA’s ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible,” said Julie Beitz, MD, director of FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation III in the FDA release.
The Food and Drug Administration has approved , a rare condition that causes extremely painful reactions when skin is exposed to light, according to an FDA announcement.
This is the first treatment approved to help patients with this condition increase their exposure to light, according to the release.
Afamelanotide, administered in a subcutaneous implant, is a melanocortin-1 receptor (MC1-R) agonist, which “increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources,” the release says.
Approval is based on a pair of parallel-group clinical trials that compared the number of hours spent in sunlight in the treatment and placebo groups. The first trial enrolled 93 patients; 48 received afamelanotide. The treated patients spent a median of 61 hours in total over 180 days in direct sunlight between 10 a.m. and 6 p.m. on days with no pain, compared with 41 hours for patients taking placebo.
The second trial assessed the total number of hours over 270 days spent outdoors between 10 a.m. and 3 p.m. on days with no pain for which “most of the day” was spent in direct sunlight. In this study, 38 patients treated with afamelanotide spent a median total of 6 hours, compared with 0.75 hours among the remaining 36 who were taking a placebo.
The most common side effects include implant site reaction, nausea, and oropharyngeal pain. The implant should be administered only by trained professionals. Because afamelanotide may cause skin darkening, it’s recommended that patients should undergo twice-yearly skin examinations. Patients are also encouraged to maintain sun protection measures to help prevent phototoxic reactions.
“Today’s approval is one example of the FDA’s ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible,” said Julie Beitz, MD, director of FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation III in the FDA release.
The Food and Drug Administration has approved , a rare condition that causes extremely painful reactions when skin is exposed to light, according to an FDA announcement.
This is the first treatment approved to help patients with this condition increase their exposure to light, according to the release.
Afamelanotide, administered in a subcutaneous implant, is a melanocortin-1 receptor (MC1-R) agonist, which “increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources,” the release says.
Approval is based on a pair of parallel-group clinical trials that compared the number of hours spent in sunlight in the treatment and placebo groups. The first trial enrolled 93 patients; 48 received afamelanotide. The treated patients spent a median of 61 hours in total over 180 days in direct sunlight between 10 a.m. and 6 p.m. on days with no pain, compared with 41 hours for patients taking placebo.
The second trial assessed the total number of hours over 270 days spent outdoors between 10 a.m. and 3 p.m. on days with no pain for which “most of the day” was spent in direct sunlight. In this study, 38 patients treated with afamelanotide spent a median total of 6 hours, compared with 0.75 hours among the remaining 36 who were taking a placebo.
The most common side effects include implant site reaction, nausea, and oropharyngeal pain. The implant should be administered only by trained professionals. Because afamelanotide may cause skin darkening, it’s recommended that patients should undergo twice-yearly skin examinations. Patients are also encouraged to maintain sun protection measures to help prevent phototoxic reactions.
“Today’s approval is one example of the FDA’s ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible,” said Julie Beitz, MD, director of FDA’s Center for Drug Evaluation and Research Office of Drug Evaluation III in the FDA release.
FDA approves trifarotene for treating acne
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
FDA approves Descovy as HIV PrEP for men and transgender women who have sex with men
The decision, backing the earlier recommendation of the FDA’s Antimicrobial Drugs Advisory Committee, was based upon results from DISCOVER, a pivotal, multiyear, global phase 3 clinical trial that evaluated the safety and efficacy of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25-mg tablets for PrEP, compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300-mg tablets).
DISCOVER included more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men.
In the trial, Descovy achieved noninferiority to Truvada.
Descovy has a Boxed Warning in its U.S. product label regarding the risk of posttreatment acute exacerbation of hepatitis B, according to the company.
The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The effectiveness of Descovy for PrEP in individuals at risk of HIV-1 from receptive vaginal sex was not tested, and thus cisgender women at risk for infection from vaginal sex were not included in the population for which the drug was approved.
The Descovy label and safety information is available here.
The FDA version of the announcement is available here.
The decision, backing the earlier recommendation of the FDA’s Antimicrobial Drugs Advisory Committee, was based upon results from DISCOVER, a pivotal, multiyear, global phase 3 clinical trial that evaluated the safety and efficacy of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25-mg tablets for PrEP, compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300-mg tablets).
DISCOVER included more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men.
In the trial, Descovy achieved noninferiority to Truvada.
Descovy has a Boxed Warning in its U.S. product label regarding the risk of posttreatment acute exacerbation of hepatitis B, according to the company.
The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The effectiveness of Descovy for PrEP in individuals at risk of HIV-1 from receptive vaginal sex was not tested, and thus cisgender women at risk for infection from vaginal sex were not included in the population for which the drug was approved.
The Descovy label and safety information is available here.
The FDA version of the announcement is available here.
The decision, backing the earlier recommendation of the FDA’s Antimicrobial Drugs Advisory Committee, was based upon results from DISCOVER, a pivotal, multiyear, global phase 3 clinical trial that evaluated the safety and efficacy of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25-mg tablets for PrEP, compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300-mg tablets).
DISCOVER included more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men.
In the trial, Descovy achieved noninferiority to Truvada.
Descovy has a Boxed Warning in its U.S. product label regarding the risk of posttreatment acute exacerbation of hepatitis B, according to the company.
The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The effectiveness of Descovy for PrEP in individuals at risk of HIV-1 from receptive vaginal sex was not tested, and thus cisgender women at risk for infection from vaginal sex were not included in the population for which the drug was approved.
The Descovy label and safety information is available here.
The FDA version of the announcement is available here.