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Novartis' Applications for MS Drug Accepted by FDA & EMA

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Novartis' Applications for MS Drug Accepted by FDA & EMA

Novartis (NVS) progresses with its MS candidate, siponimod, as both the FDA and the EMA accepts the applications for the drug.

Novartis AG NVS announced that both the FDA and the European Medicines Agency (EMA) have accepted the New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, for pipeline candidate, siponimod (BAF312).

Siponimod, an experimental oral once-daily selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, is being evaluated for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.

The filings were based on positive data from the phase III study, EXPAND, which showed that siponimod had beneficial effects on disability relapses and magnetic resonance imaging (MRI) disease activities in typical SPMS patients.

Novartis used a review voucher to expedite the review of siponimod in the United States. A decision on approval is expected in March 2019 in the United States and late 2019 in Europe.

Additionally, Novartis conducted a phase II randomized placebo-controlled, adaptive dose-ranging study, BOLD, in patients with RRMS. Results from the study showed that siponimod significantly reduced the annualized rate of relapses (ARR) for more than six months compared to placebo.

A tentative approval will boost Novartis’ MS portfolio, which includes approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. The drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease, in Europe.

The company has other pipeline candidates like OMB157 (ofatumumab), a fully human monoclonal antibody being evaluated for relapsing MS.

Novartis’ generic division, Sandoz markets Glatopa, a generic version of Teva Pharmaceuticals’ TEVA Copaxone (both 20 and 40 mg), in partnership with Momenta Pharmaceuticals MNTA.

Approval of new drugs and label expansion of existing drugs bode well for Novartis. The company’s shares have gained 5.5% in the year so far compared with the industry’s growth of 10%.


We note that Biogen, Inc. BIIB holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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