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").
The applications are supported by data from the Phase III EXPAND trial which showed that siponimod reduced the risk of six-month confirmed disability progression by 26% compared with placebo (20% vs. 26%, HR=0.74, 95% CI: 0.6, 0.92, p=0.0058) in SPMS patients (see "Novartis Planning Submissions for Secondary Progressive MS Candidate").
Siponimod is a second-generation sphingosine 1-phosphate receptor 1 (S1PR1; S1P1; EDG1) agonist. It was designed to avoid some of the cardiovascular side effects seen with Novartis' MS drug Gilenya fingolimod, a first-generation S1P receptor agonist (see "Devil Is in the Dosing").
Celgene Corp. (NASDAQ:CELG) is developing ozanimod (RPC1063), a selective S1PR1 and S1PR5 modulator. In February, FDA issued a refusal to file letter for ozanimod in relapsing MS (see "Rocky Road").
In July, Celgene said it expects to submit in 1Q19 regulatory applications in the U.S. and EU for ozanimod.
(C) 2018 M2 COMMUNICATIONS, source M2 PressWIRE