Swiss pharma giant Novartis AG NVS announced that the FDA has approved pipeline candidate Mayzent (siponimod), a next generation, selective sphingosine 1-phosphate receptor modulator, for the treatment of adults with relapsing forms of multiple sclerosis (MS).
The FDA has approved the drug for the treatment of secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).
The approval was based on data from the phase III EXPAND trial, a randomized, double-blind, placebo-controlled study which compared the efficacy and safety of Mayzent with that of placebo in SPMS patients.
The results showed that Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline.
The drug is also under review in Europe.
The approval will strengthen Novartis’ MS portfolio, which includes approved drugs like Gilenya and Extavia (interferon beta-1b for subcutaneous injection). Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. The drug is approved in Europe to treat patients with RRMS and SPMS with active disease. Novartis also has other MS candidates in the pipeline like OMB157 (ofatumumab), which is being evaluated for relapsing MS in a phase III program. The program, which was initiated in August 2016, is fully enrolled and on track for completion in 2019.
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 the company.
Novartis’ shares have gained 12.7% in the year so far compared with the industry’s growth of 6%.
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.
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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