Novartis receives USFDA approval for Mayzent

Novartis has recently announced that the US Food and Drug Administration (FDA) has approved Mayzent (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system), relapsing remitting disease, and active secondary progressive disease, in adults. SPMS is a debilitating form of multiple sclerosis characterized by progressive and irreversible neurological disability. Patients will not require a first-dose observation unless they have certain pre-existing cardiac conditions.

The approval of Mayzent is based on results from the Phase-III Expand study, a randomized, double-blind, placebo-controlled study, comparing the efficacy and safety of Mayzent versus placebo in people living with SPMS. Patients enrolled in Expand were representatives of a typical SPMS population: at study initiation, patients had a mean age of 48 years, had been living with MS for approximately 16 years and more than 50 percent had a median expanded disability status scale (EDSS) score of 6.0 and relied on a walking aid.

Mayzent significantly reduced the risk of three-month confirmed disability progression. Mayzent also reduced the annualized relapse rate (ARR) by 55 percent.

The company is committed to bringing Mayzent to patients worldwide, and additional regulatory filings are currently underway with other health authorities outside the U.S. Regulatory action for Mayzent in the European Union is anticipated in late 2019, with additional regulatory action anticipated in Switzerland, Japan, Australia, and Canada this year.