BioCentury
ARTICLE | Clinical News

FDA, EMA to review Novartis' siponimod for secondary progressive MS

October 12, 2018 5:34 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and MAA have accepted applications for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS). The PDUFA date for the NDA is in March 2019; Novartis expects a decision from EMA in late 2019.

The pharma used a Priority Review voucher to speed siponimod's review. Novartis spokesperson Eric Althoff said the company used the voucher it purchased from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) in 2017; Novartis paid $130 million for the voucher (see "Novartis Buys Priority Review Voucher from Ultragenyx")...