CHMP has recommended approval of Ilaris (canakinumab) in Europe to treat three rare and distinct Periodic Fever Syndromes.- Novartis

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ilaris (canakinumab) in Europe to treat three rare and distinct Periodic Fever Syndromes. If approved, Ilaris will be the first and only approved biologic treatment in Europe for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).

The CHMP positive opinion, which also recommends the use of a new formulation which is a 150 mg/ml solution for injection, is based on results from the pivotal Phase III CLUSTER study. Results 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. Data show Ilaris to be a well-tolerated and effective treatment for these three rare conditions. All three conditions are part of a group of rare autoinflammatory diseases called Periodic Fever Syndromes, which are also referred to as Hereditary Periodic Fevers (HPF). These can 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. The most common syndrome is FMF, which mainly affects people of Eastern Mediterranean ancestry. It affects 1 in 250 to 1 in 1,000 individuals in these populations, many of whom are children.

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. Ilaris was recently approved by the European Commission for patients with Adult-Onset Still's Disease (AOSD), and is also available for gout.