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The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.
The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.
The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.
AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.
The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.
Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.
The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.
The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.
The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.
AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.
The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.
Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.
The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.
The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.
The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.
AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.
The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.
Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.