MS drug market heats up as FDA backs Novartis’ new pill

The FDA has approved Novartis’ Mayzent (siponimod) multiple sclerosis pill for relapsing forms of the disease, dealing a potential blow to a much-delayed rival from Celgene. Mayzent’s approval comes hot on the heels of Celgene’s delayed filing for its MS drug ozanimod, which should have been reviewed by the FDA by now had it not been for a botched filing early last year. The FDA approved Mayzent (siponimod) for adults with relapsing forms of the disease, including secondary progressive multiple sclerosis (SPMS), with active disease, relapsing-remitting multiple sclerosis (RRMS) with active disease, and relapsing-remitting MS (RRMS) and clinically isolated syndrome (CIS). SPMS is a debilitating form of multiple sclerosis (MS) characterized by progressive and irreversible neurological disability. Mayzent is expected to be available in the US in about one week.