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FDA begins priority review of cemiplimab for advanced cutaneous squamous cell carcinoma
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
The Food and Drug Administration will conduct a priority review of cemiplimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (SCC), the companies developing the treatment announced on April 30.
Cemiplimab, a human monoclonal antibody being developed by Regeneron Pharmaceuticals and Sanofi, targets the checkpoint inhibitor programmed cell death protein-1 (PD-1). The drug was previously granted Breakthrough Therapy status by the FDA in September 2017.
No safety and efficacy data are available for cemiplimab at this time.
Find the full press release on the Regeneron website.
FDA: More COPD patients can use triple therapy
The Food and Drug Administration has approved a new indication for the chronic obstructive pulmonary disease (COPD) therapy fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta), which allows physicians to prescribe the drug to a broader class of COPD patients, according to a statement from two pharmaceutical companies.
“Following the initial approval of Trelegy Ellipta in September, we have analysed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with [COPD],” said Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, in the statement. “We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly.”
The results of the IMPACT trial, which was the first study to compare a single-inhaler triple therapy with two dual therapies, were published on April 18 (N Engl J Med 2018. doi: 10.1056/NEJMoa1713901).
This study randomized patients to 52 weeks of either triple inhaled therapy involving a once-daily combination of 100 mcg fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol.
After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction, compared with vilanterol-umeclidinium (P less than .001 for both).
The Food and Drug Administration has approved a new indication for the chronic obstructive pulmonary disease (COPD) therapy fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta), which allows physicians to prescribe the drug to a broader class of COPD patients, according to a statement from two pharmaceutical companies.
“Following the initial approval of Trelegy Ellipta in September, we have analysed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with [COPD],” said Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, in the statement. “We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly.”
The results of the IMPACT trial, which was the first study to compare a single-inhaler triple therapy with two dual therapies, were published on April 18 (N Engl J Med 2018. doi: 10.1056/NEJMoa1713901).
This study randomized patients to 52 weeks of either triple inhaled therapy involving a once-daily combination of 100 mcg fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol.
After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction, compared with vilanterol-umeclidinium (P less than .001 for both).
The Food and Drug Administration has approved a new indication for the chronic obstructive pulmonary disease (COPD) therapy fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta), which allows physicians to prescribe the drug to a broader class of COPD patients, according to a statement from two pharmaceutical companies.
“Following the initial approval of Trelegy Ellipta in September, we have analysed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with [COPD],” said Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, in the statement. “We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly.”
The results of the IMPACT trial, which was the first study to compare a single-inhaler triple therapy with two dual therapies, were published on April 18 (N Engl J Med 2018. doi: 10.1056/NEJMoa1713901).
This study randomized patients to 52 weeks of either triple inhaled therapy involving a once-daily combination of 100 mcg fluticasone furoate, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol.
After 1 year, the rate of moderate to severe COPD exacerbations in the triple-therapy group was 0.91 per year, compared with 1.07 in the fluticasone furoate–vilanterol group and 1.21 in the vilanterol-umeclidinium group. This translated to a 15% reduction with triple therapy compared with fluticasone furoate–vilanterol and a 25% reduction, compared with vilanterol-umeclidinium (P less than .001 for both).
FDA approves epinephrine autoinjector for infants and toddlers
according to a press release from Kaléo, a privately-held pharmaceutical company.
“Anaphylactic reactions can be frightening and serious, and when experienced by the very young, some of whom can’t communicate about what’s happening, these episodes can be particularly alarming,” Vivian Hernandez-Trujillo, MD, a pediatric allergist and fellow of the American Academy of Allergy, Asthma and Immunology, said in a statement. “Now, caregivers can have the AUVI-Q 0.1 mg in hand to respond to an allergic emergency and safely administer epinephrine to infants and toddlers.”
The approval comes at a time when a higher percentage of children are being admitted to the hospital for food-related anaphylaxis: a 130% increase among children aged 0-4 years and a 196% increase in children aged 5-17 years.
The epinephrine autoinjector will be available for $0 out of pocket for commercially insured patients using the AUVI-Q AffordAbility Program and Direct Delivery Service starting May 1, 2018. More information concerning this EAI can be found here.
according to a press release from Kaléo, a privately-held pharmaceutical company.
“Anaphylactic reactions can be frightening and serious, and when experienced by the very young, some of whom can’t communicate about what’s happening, these episodes can be particularly alarming,” Vivian Hernandez-Trujillo, MD, a pediatric allergist and fellow of the American Academy of Allergy, Asthma and Immunology, said in a statement. “Now, caregivers can have the AUVI-Q 0.1 mg in hand to respond to an allergic emergency and safely administer epinephrine to infants and toddlers.”
The approval comes at a time when a higher percentage of children are being admitted to the hospital for food-related anaphylaxis: a 130% increase among children aged 0-4 years and a 196% increase in children aged 5-17 years.
The epinephrine autoinjector will be available for $0 out of pocket for commercially insured patients using the AUVI-Q AffordAbility Program and Direct Delivery Service starting May 1, 2018. More information concerning this EAI can be found here.
according to a press release from Kaléo, a privately-held pharmaceutical company.
“Anaphylactic reactions can be frightening and serious, and when experienced by the very young, some of whom can’t communicate about what’s happening, these episodes can be particularly alarming,” Vivian Hernandez-Trujillo, MD, a pediatric allergist and fellow of the American Academy of Allergy, Asthma and Immunology, said in a statement. “Now, caregivers can have the AUVI-Q 0.1 mg in hand to respond to an allergic emergency and safely administer epinephrine to infants and toddlers.”
The approval comes at a time when a higher percentage of children are being admitted to the hospital for food-related anaphylaxis: a 130% increase among children aged 0-4 years and a 196% increase in children aged 5-17 years.
The epinephrine autoinjector will be available for $0 out of pocket for commercially insured patients using the AUVI-Q AffordAbility Program and Direct Delivery Service starting May 1, 2018. More information concerning this EAI can be found here.
Bipolar and seizure medication linked with serious immune system reaction
The Food and Drug Administration has issued a warning that the seizure and bipolar medication Lamictal (lamotrigine) can cause a rare but potentially life-threatening immune response.
This life-threatening immune response, known as hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled immune response and can present as a persistent fever greater than 101° F. HLH can also lead to severe issues with blood cells and organs like the liver, kidneys, and lungs.
Lamotrigine is commonly used as a maintenance treatment for patients with bipolar disorder to help manage depression and mood episodes of mania and hypomania. Patients who abruptly stop taking lamotrigine before talking to their physician can suffer seizures, as well as new or worsening mental health issues.
The FDA is recommending that health care providers be aware of the connection between lamotrigine and HLH and be able to recognize and treat the immune response promptly to improve outcomes and decrease mortality. This can be difficult because of the nonspecific nature of HLH symptoms like fever and rash. HLH is commonly confused with another immune-related reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients should be evaluated if they develop fever or rash and immediately discontinue use of lamotrigine if HLH is suspected.
The basis for the new warning is eight cases worldwide of confirmed or suspected HLH involving “reasonable evidence that lamotrigine was the cause of HLH ... based on the timing of events and the order in which they occurred,” the agency said, noting that this number includes only reports submitted to the FDA and found in the medical literature during the 24-year approval history of the drug, so there are likely additional cases about which we are unaware. The eight patients were all hospitalized and received drug and other medical treatments, with one dying.
HLH can be diagnosed if a patient has at least five of the following eight signs or symptoms: fever and rash; enlarged spleen; cytopenias; elevated blood triglycerides and high levels of ferritin or low levels of fibrinogen; hemophagocytosis confirmed via bone marrow, spleen, or lymph node biopsy; decreased or absent natural killer (NK) cell activity; and elevated levels of CD25 in the blood.
Other signs and symptoms may include: enlarged liver, swollen lymph nodes, yellowing of the skin or eyes, unusual bleeding, disturbances in vision, and trouble walking.
The FDA encourages health care providers and patients to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The Food and Drug Administration has issued a warning that the seizure and bipolar medication Lamictal (lamotrigine) can cause a rare but potentially life-threatening immune response.
This life-threatening immune response, known as hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled immune response and can present as a persistent fever greater than 101° F. HLH can also lead to severe issues with blood cells and organs like the liver, kidneys, and lungs.
Lamotrigine is commonly used as a maintenance treatment for patients with bipolar disorder to help manage depression and mood episodes of mania and hypomania. Patients who abruptly stop taking lamotrigine before talking to their physician can suffer seizures, as well as new or worsening mental health issues.
The FDA is recommending that health care providers be aware of the connection between lamotrigine and HLH and be able to recognize and treat the immune response promptly to improve outcomes and decrease mortality. This can be difficult because of the nonspecific nature of HLH symptoms like fever and rash. HLH is commonly confused with another immune-related reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients should be evaluated if they develop fever or rash and immediately discontinue use of lamotrigine if HLH is suspected.
The basis for the new warning is eight cases worldwide of confirmed or suspected HLH involving “reasonable evidence that lamotrigine was the cause of HLH ... based on the timing of events and the order in which they occurred,” the agency said, noting that this number includes only reports submitted to the FDA and found in the medical literature during the 24-year approval history of the drug, so there are likely additional cases about which we are unaware. The eight patients were all hospitalized and received drug and other medical treatments, with one dying.
HLH can be diagnosed if a patient has at least five of the following eight signs or symptoms: fever and rash; enlarged spleen; cytopenias; elevated blood triglycerides and high levels of ferritin or low levels of fibrinogen; hemophagocytosis confirmed via bone marrow, spleen, or lymph node biopsy; decreased or absent natural killer (NK) cell activity; and elevated levels of CD25 in the blood.
Other signs and symptoms may include: enlarged liver, swollen lymph nodes, yellowing of the skin or eyes, unusual bleeding, disturbances in vision, and trouble walking.
The FDA encourages health care providers and patients to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The Food and Drug Administration has issued a warning that the seizure and bipolar medication Lamictal (lamotrigine) can cause a rare but potentially life-threatening immune response.
This life-threatening immune response, known as hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled immune response and can present as a persistent fever greater than 101° F. HLH can also lead to severe issues with blood cells and organs like the liver, kidneys, and lungs.
Lamotrigine is commonly used as a maintenance treatment for patients with bipolar disorder to help manage depression and mood episodes of mania and hypomania. Patients who abruptly stop taking lamotrigine before talking to their physician can suffer seizures, as well as new or worsening mental health issues.
The FDA is recommending that health care providers be aware of the connection between lamotrigine and HLH and be able to recognize and treat the immune response promptly to improve outcomes and decrease mortality. This can be difficult because of the nonspecific nature of HLH symptoms like fever and rash. HLH is commonly confused with another immune-related reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients should be evaluated if they develop fever or rash and immediately discontinue use of lamotrigine if HLH is suspected.
The basis for the new warning is eight cases worldwide of confirmed or suspected HLH involving “reasonable evidence that lamotrigine was the cause of HLH ... based on the timing of events and the order in which they occurred,” the agency said, noting that this number includes only reports submitted to the FDA and found in the medical literature during the 24-year approval history of the drug, so there are likely additional cases about which we are unaware. The eight patients were all hospitalized and received drug and other medical treatments, with one dying.
HLH can be diagnosed if a patient has at least five of the following eight signs or symptoms: fever and rash; enlarged spleen; cytopenias; elevated blood triglycerides and high levels of ferritin or low levels of fibrinogen; hemophagocytosis confirmed via bone marrow, spleen, or lymph node biopsy; decreased or absent natural killer (NK) cell activity; and elevated levels of CD25 in the blood.
Other signs and symptoms may include: enlarged liver, swollen lymph nodes, yellowing of the skin or eyes, unusual bleeding, disturbances in vision, and trouble walking.
The FDA encourages health care providers and patients to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
FDA advisory committee votes to recommend update to celecoxib safety labeling
SILVER SPRING, MD. – An FDA advisory committee voted (15 yes, 5 no, 1 abstention) to update the safety information in the label of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), for use in patients with osteoarthritis (OA) and rheumatoid arthritis, on the basis of results of the PRECISION trial.
A Joint Meeting ofthe Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened April 24-25 to address two issues, the first being the consideration of Pfizer’s application for celecoxib and the second, to assess the safety of celecoxib and other common NSAIDs like ibuprofen and naproxen.
The randomized controlled PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial compared celecoxib, naproxen, and ibuprofen and their cardiovascular outcomes. The PRECISION trial was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that the rates of cardiovascular events (cardiovascular death, myocardial infarction, or stroke) were 2.3% with celecoxib, 2.5% with naproxen, and 2.7% with ibuprofen during a follow-up approaching 3 years, showing noninferiority for celecoxib.
In a post hoc analysis presented by Steven Nissen, MD, patients taking ibuprofen and naproxen experienced adjudicated cardiovascular, GI, or renal events 28% and 15% more than did patients taking celecoxib.
The results of the study could inform clinical strategy, said Dr. Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “For arthritis patients who require NSAIDs to achieve an acceptable quality of life, particularly those at high cardiovascular, GI, or renal risk, the PRECISION trial suggests that a clinical strategy of starting patients on celecoxib 200 mg daily may be the safest approach, reserving full therapeutic doses of ibuprofen and naproxen for patients who do not respond to celecoxib."
SILVER SPRING, MD. – An FDA advisory committee voted (15 yes, 5 no, 1 abstention) to update the safety information in the label of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), for use in patients with osteoarthritis (OA) and rheumatoid arthritis, on the basis of results of the PRECISION trial.
A Joint Meeting ofthe Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened April 24-25 to address two issues, the first being the consideration of Pfizer’s application for celecoxib and the second, to assess the safety of celecoxib and other common NSAIDs like ibuprofen and naproxen.
The randomized controlled PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial compared celecoxib, naproxen, and ibuprofen and their cardiovascular outcomes. The PRECISION trial was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that the rates of cardiovascular events (cardiovascular death, myocardial infarction, or stroke) were 2.3% with celecoxib, 2.5% with naproxen, and 2.7% with ibuprofen during a follow-up approaching 3 years, showing noninferiority for celecoxib.
In a post hoc analysis presented by Steven Nissen, MD, patients taking ibuprofen and naproxen experienced adjudicated cardiovascular, GI, or renal events 28% and 15% more than did patients taking celecoxib.
The results of the study could inform clinical strategy, said Dr. Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “For arthritis patients who require NSAIDs to achieve an acceptable quality of life, particularly those at high cardiovascular, GI, or renal risk, the PRECISION trial suggests that a clinical strategy of starting patients on celecoxib 200 mg daily may be the safest approach, reserving full therapeutic doses of ibuprofen and naproxen for patients who do not respond to celecoxib."
SILVER SPRING, MD. – An FDA advisory committee voted (15 yes, 5 no, 1 abstention) to update the safety information in the label of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), for use in patients with osteoarthritis (OA) and rheumatoid arthritis, on the basis of results of the PRECISION trial.
A Joint Meeting ofthe Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened April 24-25 to address two issues, the first being the consideration of Pfizer’s application for celecoxib and the second, to assess the safety of celecoxib and other common NSAIDs like ibuprofen and naproxen.
The randomized controlled PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial compared celecoxib, naproxen, and ibuprofen and their cardiovascular outcomes. The PRECISION trial was undertaken after another selective COX-2 inhibitor, rofecoxib (Vioxx), was withdrawn from the market because of associated cardiovascular events. It compared the three drugs among more than 24,000 patients with painful arthritis and elevated cardiovascular risk.
Main results showed that the rates of cardiovascular events (cardiovascular death, myocardial infarction, or stroke) were 2.3% with celecoxib, 2.5% with naproxen, and 2.7% with ibuprofen during a follow-up approaching 3 years, showing noninferiority for celecoxib.
In a post hoc analysis presented by Steven Nissen, MD, patients taking ibuprofen and naproxen experienced adjudicated cardiovascular, GI, or renal events 28% and 15% more than did patients taking celecoxib.
The results of the study could inform clinical strategy, said Dr. Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “For arthritis patients who require NSAIDs to achieve an acceptable quality of life, particularly those at high cardiovascular, GI, or renal risk, the PRECISION trial suggests that a clinical strategy of starting patients on celecoxib 200 mg daily may be the safest approach, reserving full therapeutic doses of ibuprofen and naproxen for patients who do not respond to celecoxib."
REPORTING FROM AN FDA ADVISORY COMMITTEE MEETING
FDA places partial hold on trials after secondary lymphoma
The drugmaker after a pediatric patient developed a secondary T-cell lymphoma.
The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.
Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.
Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.
The drugmaker after a pediatric patient developed a secondary T-cell lymphoma.
The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.
Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.
Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.
The drugmaker after a pediatric patient developed a secondary T-cell lymphoma.
The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.
Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.
Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.
FDA advisory committee recommends baricitinib 2 mg to treat rheumatoid arthritis
The Food and Drug Administration Arthritis Advisory Committee has voted to recommend the 2-mg dose of baricitinib, an orally administered Janus kinase (JAK) inhibitor, to treat adults with moderate to severe rheumatoid arthritis who have responded inadequately or poorly to methotrexate but rejected a 4-mg dose of the same drug.
In separate votes on efficacy of the 2-mg and 4-mg doses of baricitinib (14-1 and 15-0, respectively), on their safety (9-6 and 4-11), and on their benefit-risk ratio (10-5 and 5-10), the advisory committee consistently backed the 2-mg dose, but the committee rejected the 4-mg dose despite its effectiveness in improving the symptoms of rheumatoid arthritis. Although the FDA does not always follow the advice of its advisory committees, it generally does.
The New Drug Application was resubmitted by Eli Lilly and Incyte. The proposed doses included a 2-mg once-daily dose and a 4-mg dose for some patients. The original submission was filed in January of 2016 with an indication to treat moderate to severe rheumatoid arthritis, but that application was rejected primarily because of concerns about thrombotic events. Other issues with the original application included inadequate safety exposure for the 2-mg dose of baricitinib, as well as inconsistent findings concerning the efficacy of the higher 4-mg dose.
The resubmission addressed several of the issues noted by the FDA, and changed the indication to treat patients with moderate to severe RA who have had an inadequate response to methotrexate. Along with the different indication, the dosing regimen shifted to 2 mg once daily. For patients who did not adequately respond to disease-modifying antirheumatic drugs (DMARDS) or had an intolerance for one or more of these drugs, a 4-mg dose was recommended; after disease activity had been controlled, a taper to 2 mg once daily could be considered.
Apart from changes in the drug dosage and indication, the resubmission also included accumulated safety data, comparative epidemiologic data concerning venous thromboembolism and pulmonary embolism, and efficacy analyses to support the new dosing recommendations.
“The risk-benefit ratio may be less good here,” stated Donald Miller, PharmD, a professor of pharmacy practice at North Dakota State University, Fargo. “If there is a safety issue, it’s more likely to be a problem with the 4-mg dose.”
Jon Russell, MD, PhD, medical director of Fibromyalgia Research and Consulting, San Antonio, felt that the manufacturer understood that the safety signal indicated that the benefits outweighed the risks with the 4-mg dose of baricitinib.
“The drug is efficacious in resistant rheumatoid arthritis, and rheumatoid arthritis is a devastating disease. Organs are being destroyed, joints as well as organs, and it’s war. We need to make the patient aware that it’s war and then fight it like it is,” he said.
Many of the committee members mentioned that the efficacies of the 2-mg and 4-mg doses were not in question, primarily based on the data from four phase 3 clinical trials.
The studies RA-BEACON (JADW), RA-BUILD (JADX), RA-BEGIN (JADZ), and RA-BEAM (JADV) were all randomized phase 3 trials that evaluated the efficacy of baricitinib in patients with moderate to severe RA.
RA-BEACON and RA-BUILD both had similar designs and compared 2-mg and 4-mg doses of baricitinib with placebo; the trials primarily differed in their patient populations.
RA-BEACON. Investigators looked at 527 randomized patients who had failed treatment with a biologic DMARD with nearly half failing multiple classes of this drug. The primary endpoint for this study was met, with the 4-mg dose showing superior results, compared with placebo, based on American College of Rheumatology (ACR) 20 scores (P less than .0001). As early as week 1 of the trial, both patients receiving 2 mg and those receiving 4 mg of baricitinib showed significant improvement, compared with placebo. By week 4, the 4-mg dose produced as much improvement as the 2-mg dose achieved over nearly 6 months. While the 4-mg dose was considered more effective, the 2-mg dose showed improvement in ACR 20 scores, change in Disease Activity Score 28 C-reactive protein (DAS28-CRP), and change in health assessment questionnaire disability index (HAQ-DI) (P less than .001). Neither the 4-mg nor the 2-mg dose was able to reduce Simple Disease Activity Index (SDAI) scores, a difficult endpoint to achieve, particularly in such a short time frame.
RA-BUILD. The researchers looked at patients who had failed treatment with conventional DMARDs and had not been treated with biologic DMARDS. The investigators looked at 684 randomized patients and saw similar results to RA-BEACON, with both the 2-mg and 4-mg doses displaying significant improvement in ACR 20, change in DAS28-CRP, and change in HAQ-DI, as well as SDAI remission which had been absent in RA-BEACON. Patients taking the 4-mg dose showed improvement in morning joint stiffness duration and severity (P less than .0001), as well as improvements in worst joint pain (P less than .0001) and tiredness (P less than .027).
RA-BEGIN. The investigators took a different approach and compared various drug combinations, including baricitinib 4 mg alone or in combination with oral methotrexate or in patients taking methotrexate who were DMARD-naive. Ultimately, this trial displayed that baricitinib 4 mg alone was superior to methotrexate, according to ACR 20 scores. This held true across all clinical measures at week 24 whether baricitinib was administered alone or in combination with methotrexate. As it had in the previously discussed trials, the 4-mg dose improved all of the previously mentioned test scores, compared with methotrexate (P less than .0001) except for modified Total Sharp Score (mTSS) (P = 0.158). When baricitinib 4 mg was used in conjunction with methotrexate, improvements in test scores, including mTSS, were statistically significant.
RA-BEAM. The researchers compared baricitinib 4 mg with placebo and adalimumab in 1,305 patients. All patients maintained a background level of methotrexate to improve the efficacy of adalimumab. Consistent with previous studies, baricitinib 4 mg outperformed other therapies and placebo in improvement in ACR 20, change in DAS28-CRP, change in HAQ-DI, and SDAI remission, as well as improvements in morning joint stiffness duration and severity, worst joint pain, and worst tiredness (P less than .0001).
Despite the clear efficacy of baricitinib 4 mg, the primary issue of contention was safety and benefit-to-risk ratio. The primary safety concerns were serious infection from opportunistic pathogens, herpes zoster, various malignancies, arterial and venous thrombosis, and laboratory abnormalities including elevated platelet counts and liver test elevations.
The Food and Drug Administration Arthritis Advisory Committee has voted to recommend the 2-mg dose of baricitinib, an orally administered Janus kinase (JAK) inhibitor, to treat adults with moderate to severe rheumatoid arthritis who have responded inadequately or poorly to methotrexate but rejected a 4-mg dose of the same drug.
In separate votes on efficacy of the 2-mg and 4-mg doses of baricitinib (14-1 and 15-0, respectively), on their safety (9-6 and 4-11), and on their benefit-risk ratio (10-5 and 5-10), the advisory committee consistently backed the 2-mg dose, but the committee rejected the 4-mg dose despite its effectiveness in improving the symptoms of rheumatoid arthritis. Although the FDA does not always follow the advice of its advisory committees, it generally does.
The New Drug Application was resubmitted by Eli Lilly and Incyte. The proposed doses included a 2-mg once-daily dose and a 4-mg dose for some patients. The original submission was filed in January of 2016 with an indication to treat moderate to severe rheumatoid arthritis, but that application was rejected primarily because of concerns about thrombotic events. Other issues with the original application included inadequate safety exposure for the 2-mg dose of baricitinib, as well as inconsistent findings concerning the efficacy of the higher 4-mg dose.
The resubmission addressed several of the issues noted by the FDA, and changed the indication to treat patients with moderate to severe RA who have had an inadequate response to methotrexate. Along with the different indication, the dosing regimen shifted to 2 mg once daily. For patients who did not adequately respond to disease-modifying antirheumatic drugs (DMARDS) or had an intolerance for one or more of these drugs, a 4-mg dose was recommended; after disease activity had been controlled, a taper to 2 mg once daily could be considered.
Apart from changes in the drug dosage and indication, the resubmission also included accumulated safety data, comparative epidemiologic data concerning venous thromboembolism and pulmonary embolism, and efficacy analyses to support the new dosing recommendations.
“The risk-benefit ratio may be less good here,” stated Donald Miller, PharmD, a professor of pharmacy practice at North Dakota State University, Fargo. “If there is a safety issue, it’s more likely to be a problem with the 4-mg dose.”
Jon Russell, MD, PhD, medical director of Fibromyalgia Research and Consulting, San Antonio, felt that the manufacturer understood that the safety signal indicated that the benefits outweighed the risks with the 4-mg dose of baricitinib.
“The drug is efficacious in resistant rheumatoid arthritis, and rheumatoid arthritis is a devastating disease. Organs are being destroyed, joints as well as organs, and it’s war. We need to make the patient aware that it’s war and then fight it like it is,” he said.
Many of the committee members mentioned that the efficacies of the 2-mg and 4-mg doses were not in question, primarily based on the data from four phase 3 clinical trials.
The studies RA-BEACON (JADW), RA-BUILD (JADX), RA-BEGIN (JADZ), and RA-BEAM (JADV) were all randomized phase 3 trials that evaluated the efficacy of baricitinib in patients with moderate to severe RA.
RA-BEACON and RA-BUILD both had similar designs and compared 2-mg and 4-mg doses of baricitinib with placebo; the trials primarily differed in their patient populations.
RA-BEACON. Investigators looked at 527 randomized patients who had failed treatment with a biologic DMARD with nearly half failing multiple classes of this drug. The primary endpoint for this study was met, with the 4-mg dose showing superior results, compared with placebo, based on American College of Rheumatology (ACR) 20 scores (P less than .0001). As early as week 1 of the trial, both patients receiving 2 mg and those receiving 4 mg of baricitinib showed significant improvement, compared with placebo. By week 4, the 4-mg dose produced as much improvement as the 2-mg dose achieved over nearly 6 months. While the 4-mg dose was considered more effective, the 2-mg dose showed improvement in ACR 20 scores, change in Disease Activity Score 28 C-reactive protein (DAS28-CRP), and change in health assessment questionnaire disability index (HAQ-DI) (P less than .001). Neither the 4-mg nor the 2-mg dose was able to reduce Simple Disease Activity Index (SDAI) scores, a difficult endpoint to achieve, particularly in such a short time frame.
RA-BUILD. The researchers looked at patients who had failed treatment with conventional DMARDs and had not been treated with biologic DMARDS. The investigators looked at 684 randomized patients and saw similar results to RA-BEACON, with both the 2-mg and 4-mg doses displaying significant improvement in ACR 20, change in DAS28-CRP, and change in HAQ-DI, as well as SDAI remission which had been absent in RA-BEACON. Patients taking the 4-mg dose showed improvement in morning joint stiffness duration and severity (P less than .0001), as well as improvements in worst joint pain (P less than .0001) and tiredness (P less than .027).
RA-BEGIN. The investigators took a different approach and compared various drug combinations, including baricitinib 4 mg alone or in combination with oral methotrexate or in patients taking methotrexate who were DMARD-naive. Ultimately, this trial displayed that baricitinib 4 mg alone was superior to methotrexate, according to ACR 20 scores. This held true across all clinical measures at week 24 whether baricitinib was administered alone or in combination with methotrexate. As it had in the previously discussed trials, the 4-mg dose improved all of the previously mentioned test scores, compared with methotrexate (P less than .0001) except for modified Total Sharp Score (mTSS) (P = 0.158). When baricitinib 4 mg was used in conjunction with methotrexate, improvements in test scores, including mTSS, were statistically significant.
RA-BEAM. The researchers compared baricitinib 4 mg with placebo and adalimumab in 1,305 patients. All patients maintained a background level of methotrexate to improve the efficacy of adalimumab. Consistent with previous studies, baricitinib 4 mg outperformed other therapies and placebo in improvement in ACR 20, change in DAS28-CRP, change in HAQ-DI, and SDAI remission, as well as improvements in morning joint stiffness duration and severity, worst joint pain, and worst tiredness (P less than .0001).
Despite the clear efficacy of baricitinib 4 mg, the primary issue of contention was safety and benefit-to-risk ratio. The primary safety concerns were serious infection from opportunistic pathogens, herpes zoster, various malignancies, arterial and venous thrombosis, and laboratory abnormalities including elevated platelet counts and liver test elevations.
The Food and Drug Administration Arthritis Advisory Committee has voted to recommend the 2-mg dose of baricitinib, an orally administered Janus kinase (JAK) inhibitor, to treat adults with moderate to severe rheumatoid arthritis who have responded inadequately or poorly to methotrexate but rejected a 4-mg dose of the same drug.
In separate votes on efficacy of the 2-mg and 4-mg doses of baricitinib (14-1 and 15-0, respectively), on their safety (9-6 and 4-11), and on their benefit-risk ratio (10-5 and 5-10), the advisory committee consistently backed the 2-mg dose, but the committee rejected the 4-mg dose despite its effectiveness in improving the symptoms of rheumatoid arthritis. Although the FDA does not always follow the advice of its advisory committees, it generally does.
The New Drug Application was resubmitted by Eli Lilly and Incyte. The proposed doses included a 2-mg once-daily dose and a 4-mg dose for some patients. The original submission was filed in January of 2016 with an indication to treat moderate to severe rheumatoid arthritis, but that application was rejected primarily because of concerns about thrombotic events. Other issues with the original application included inadequate safety exposure for the 2-mg dose of baricitinib, as well as inconsistent findings concerning the efficacy of the higher 4-mg dose.
The resubmission addressed several of the issues noted by the FDA, and changed the indication to treat patients with moderate to severe RA who have had an inadequate response to methotrexate. Along with the different indication, the dosing regimen shifted to 2 mg once daily. For patients who did not adequately respond to disease-modifying antirheumatic drugs (DMARDS) or had an intolerance for one or more of these drugs, a 4-mg dose was recommended; after disease activity had been controlled, a taper to 2 mg once daily could be considered.
Apart from changes in the drug dosage and indication, the resubmission also included accumulated safety data, comparative epidemiologic data concerning venous thromboembolism and pulmonary embolism, and efficacy analyses to support the new dosing recommendations.
“The risk-benefit ratio may be less good here,” stated Donald Miller, PharmD, a professor of pharmacy practice at North Dakota State University, Fargo. “If there is a safety issue, it’s more likely to be a problem with the 4-mg dose.”
Jon Russell, MD, PhD, medical director of Fibromyalgia Research and Consulting, San Antonio, felt that the manufacturer understood that the safety signal indicated that the benefits outweighed the risks with the 4-mg dose of baricitinib.
“The drug is efficacious in resistant rheumatoid arthritis, and rheumatoid arthritis is a devastating disease. Organs are being destroyed, joints as well as organs, and it’s war. We need to make the patient aware that it’s war and then fight it like it is,” he said.
Many of the committee members mentioned that the efficacies of the 2-mg and 4-mg doses were not in question, primarily based on the data from four phase 3 clinical trials.
The studies RA-BEACON (JADW), RA-BUILD (JADX), RA-BEGIN (JADZ), and RA-BEAM (JADV) were all randomized phase 3 trials that evaluated the efficacy of baricitinib in patients with moderate to severe RA.
RA-BEACON and RA-BUILD both had similar designs and compared 2-mg and 4-mg doses of baricitinib with placebo; the trials primarily differed in their patient populations.
RA-BEACON. Investigators looked at 527 randomized patients who had failed treatment with a biologic DMARD with nearly half failing multiple classes of this drug. The primary endpoint for this study was met, with the 4-mg dose showing superior results, compared with placebo, based on American College of Rheumatology (ACR) 20 scores (P less than .0001). As early as week 1 of the trial, both patients receiving 2 mg and those receiving 4 mg of baricitinib showed significant improvement, compared with placebo. By week 4, the 4-mg dose produced as much improvement as the 2-mg dose achieved over nearly 6 months. While the 4-mg dose was considered more effective, the 2-mg dose showed improvement in ACR 20 scores, change in Disease Activity Score 28 C-reactive protein (DAS28-CRP), and change in health assessment questionnaire disability index (HAQ-DI) (P less than .001). Neither the 4-mg nor the 2-mg dose was able to reduce Simple Disease Activity Index (SDAI) scores, a difficult endpoint to achieve, particularly in such a short time frame.
RA-BUILD. The researchers looked at patients who had failed treatment with conventional DMARDs and had not been treated with biologic DMARDS. The investigators looked at 684 randomized patients and saw similar results to RA-BEACON, with both the 2-mg and 4-mg doses displaying significant improvement in ACR 20, change in DAS28-CRP, and change in HAQ-DI, as well as SDAI remission which had been absent in RA-BEACON. Patients taking the 4-mg dose showed improvement in morning joint stiffness duration and severity (P less than .0001), as well as improvements in worst joint pain (P less than .0001) and tiredness (P less than .027).
RA-BEGIN. The investigators took a different approach and compared various drug combinations, including baricitinib 4 mg alone or in combination with oral methotrexate or in patients taking methotrexate who were DMARD-naive. Ultimately, this trial displayed that baricitinib 4 mg alone was superior to methotrexate, according to ACR 20 scores. This held true across all clinical measures at week 24 whether baricitinib was administered alone or in combination with methotrexate. As it had in the previously discussed trials, the 4-mg dose improved all of the previously mentioned test scores, compared with methotrexate (P less than .0001) except for modified Total Sharp Score (mTSS) (P = 0.158). When baricitinib 4 mg was used in conjunction with methotrexate, improvements in test scores, including mTSS, were statistically significant.
RA-BEAM. The researchers compared baricitinib 4 mg with placebo and adalimumab in 1,305 patients. All patients maintained a background level of methotrexate to improve the efficacy of adalimumab. Consistent with previous studies, baricitinib 4 mg outperformed other therapies and placebo in improvement in ACR 20, change in DAS28-CRP, change in HAQ-DI, and SDAI remission, as well as improvements in morning joint stiffness duration and severity, worst joint pain, and worst tiredness (P less than .0001).
Despite the clear efficacy of baricitinib 4 mg, the primary issue of contention was safety and benefit-to-risk ratio. The primary safety concerns were serious infection from opportunistic pathogens, herpes zoster, various malignancies, arterial and venous thrombosis, and laboratory abnormalities including elevated platelet counts and liver test elevations.
MenB vaccine receives breakthrough therapy designation for children aged 1-9 years
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
FDA approves osimertinib for first-line advanced EGFR-mutated NSCLC
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
FDA approves new drug for thrombocytopenia
with chronic immune thrombocytopenia (ITP).
The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.
Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.
Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.
Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.
with chronic immune thrombocytopenia (ITP).
The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.
Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.
Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.
Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.
with chronic immune thrombocytopenia (ITP).
The Food and Drug Administration approved the oral spleen tyrosine kinase (SYK) inhibitor, which works by impeding platelet destruction, on April 17. Its approval was based on data from FIT clinical program, including two randomized placebo-controlled phase 3 trials.
Physicians are advised to monitor blood pressure and liver function with the drug. Fostamatinib may interact with CYP3A4 inhibitors and inducers. Concomitant use of fostamatinib with CYP3A4 inhibitors increases exposure to R406 – the drug’s major metabolite – and may increase the risk of adverse reactions. Use with strong CYP3A4 inducers is not recommended because it reduces exposure to R406.
Women of reproductive potential should be advised to use appropriate contraception while using fostamatinib and for a month after stopping the drug; pregnant women should be told of potential risk to the fetus. Advise women not to breastfeed during treatment and for at least 1 month after the last dose, according to a press statement.
Rigel Pharmaceuticals plans to release the drug in the United States in late May 2018.