Novartis has picked up three new indications for its anti-inflammatory Ilaris in the US, allowing its use to treat three rare and distinct types of Periodic Fever Syndromes.
The decision sees Ilaris (canakinumab) become the first and only biologic treatment for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF) approved by the US Food and Drug Administration.
All three are part of a group of rare autoinflammatory diseases, that cause disabling and persistent fevers which may be accompanied by joint pain, swelling, muscle pain and skin rashes with complications that can be life-threatening.
"Gaining three simultaneous FDA approvals of Ilaris is a momentous turning point for people who suffer with these severe, debilitating diseases," said Paul Hudson, CEO, Novartis Pharmaceuticals. "There is a significant unmet need in these conditions, particularly in children".
Clearance is based on data from the pivotal 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 FMF2. As a result of the superior data, the FDA granted Ilaris Breakthrough Therapy status and priority reviews for each of the three Periodic Fever Syndrome conditions.
The drug is already approved and marketed in the US as an effective and well-tolerated treatment for another Periodic Fever Syndrome condition - Cryopyrin-Associated Periodic Syndromes (CAPS), and another autoinflammatory condition – Systemic Juvenile Idiopathic Arthritis. Across the pond, Ilaris was recently approved by the European Commission for patients with Adult-Onset Still's Disease (AOSD), and is also available for gout.