BASEL (dpa-AFX) - Novartis (NVS) announced 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. 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.
Novartis noted that, if approved, Ilaris will be the first and only approved biologic treatment in Europe for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency and Familial Mediterranean Fever.
In August 2016, the European Commission approved Ilaris for a license extension to treat patients with Adult-Onset Still's Disease, a rare type of inflammatory arthritis.
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