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FDA, EMA to review Novartis' siponimod for secondary progressive MS
October 8, 2018 6:27 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 Buying Ultragenyx's Priority Review Voucher"). ...
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