FDA Awards Novartis’ Ilaris Three Approvals in Exceptional Fever Syndromes
Novartis received three simultaneous FDA approvals for Ilaris (canakinumab), to expand its label to include three distinct types of rare autoinflammatory diseases known as periodic fever syndromes.
Ilaris is the first biologic treatment approved by the FDA for tumor necrosis factor receptor-associated periodic syndrome; hyperimmunoglobulin D syndrome, or mevalonate kinase deficiency; and familial Mediterranean fever, according to Novartis.
The FDA approvals are based on a Phase III study that showed sustained disease control compared to placebo through 16 weeks. The FDA previously granted Ilaris a Breakthrough Therapy designation and priority reviews for each of the three conditions.