The Food and Drug Administration (FDA) has granted three approvals for the expanded use of Ilaris (canakinumab; Novartis) for patients with rare Periodic Fever Syndrome conditions.
The Food and Drug Administration (FDA) has granted three approvals for the expanded use of Ilaris (canakinumab; Novartis) for patients with rare Periodic Fever Syndrome conditions. Ilaris is the first and only FDA-approved biologic treatment for patients with Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).
The FDA approvals are based on results from the Phase III CLUSTER study which showed rapid (at Day 15) and sustained disease control with Ilaris compared to placebo through 16 weeks, in patients with either TRAPS, HIDS/MKD or FMF. As a result of the positive data, the FDA granted Ilaris Breakthrough Therapy status and priority reviews for each of the three Periodic Fever Syndrome conditions.
Ilaris is a selective, high-affinity, human monoclonal antibody that inhibits Interleukin-1 (IL-1) beta. It works by blocking the action of IL-1 beta for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production. Ilaris is already approved as a treatment for another Periodic Fever Syndrome condition – Cryopyrin-Associated Periodic Syndromes, as well as Systemic Juvenile Idiopathic Arthritis.
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