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Ilaris Receives Three Simultaneous FDA Approvals for Periodic Fever Syndromes
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Novartis announced the FDA granted three simultaneous approvals for the expanded use of Ilaris to treat three distinct types of periodic fever syndromes.
“For the first time, patients with [tumor necrosis factor receptor associated periodic syndrome] TRAPS and [hyperimmunoglobulin D syndrome/mevalonate kinase deficiency] HIDS/MKD, two painful and life altering diseases, have access to a treatment that may help improve their quality of life,” Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA’s Center for Drug Evaluation and Research, said in an FDA press release.
Based on results from the phase 3 CLUSTER study, Ilaris (canakinumab, Novartis Pharmaceuticals) is the first and only FDA-approved biologic treatment for TRAPS, HIDS/MKD and familial Mediterranean fever, according to a company press release. At 16 weeks, patients prescribed canakinumab had rapid and sustained disease control vs. patients who received placebo, the release noted.
“Gaining three simultaneous FDA approvals of Ilaris is a momentous turning point for people who suffer with these severe, debilitating diseases,” Paul Hudson, chief executive officer of Novartis Pharmaceuticals, said in the release. “There is a significant unmet need in these conditions, particularly in children, and Novartis is proud to provide a new treatment option to those who so desperately need it.”
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