Novartis NDA Accepted for Multiple Sclerosis Drug

FDA has accepted for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis (SPMS) in adults. If approved, siponimod would be the first oral treatment approved for SPMS that significantly delays disability progression, Novartis says. The submission was filed with a priority review voucher and an agency decision is expect in 3/2019.

The NDA is based on data from the placebo-controlled Phase 3 EXPAND study comparing siponimod versus placebo in people living with typical SPMS. At study initiation, more than 50% of patients used a walking aid. Novartis says data showed that siponimod significantly reduced the risk of three-month confirmed disability progression. The therapy also meaningfully delayed the risk of six-month confirmed disability progression (26% vs placebo) and demonstrated favorable outcomes in other relevant measures of MS disease activity and progression relevant measures, it says.