Japan Approves Novartis’ MS Drug Gilenya and CAPS Treatment Ilaris

Japanese regulatory authorities approved Novartis’ once-daily multiple sclerosis (MS) drug Gilenya and also the firm’s IL-1 beta-targeting mAb Ilaris for the treatment of adults and children with the autoinflammatory disorder cryopyrin-associated periodic syndrome (CAPS).

The Gilenya sanction covers use of the drug for preventing relapse and delaying progression of physical disability in adult MS patients. The only other drug licensed in Japan for preventing relapse of MS patients is interferon beta. Gilenya is already approved in over 50 countries including the U.S. and nations in the EU.

Clearance of Ilaris in Japan represents the first for a therapy for CAPS. It covers use of the drug for treating all CAPS disease phenotypes including familial cold auto-inflammatory syndrome, Muckle-Wells syndrome, and neonatal-onset multisystem inflammatory disease. The drug is currently approved in 50 or so countries including the U.S. and those in the EU for the treatment of adults and children with CAPS. The compound is also being evaluated in diseases including juvenile idiopathic arthritis and gouty arthritis as well as for the secondary prevention of cardiovascular events.