Novartis AG (NVS - Free Report) announced encouraging top-line results from the phase IIIb ASSESS study on multiple sclerosis drug, Gilenya.
The trial evaluated the efficacy and safety of oral, once daily Gilenya (fingolimod) 0.5mg and 0.25mg compared to once daily subcutaneous injections of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone (glatiramer acetate) 20mg, in patients with relapsing remitting multiple sclerosis (RRMS).
The results show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate (ARR) compared to Copaxone. Patients treated with Gilenya 0.5mg experienced a 40.7% relative reduction in the rate of relapses over a period of one year compared to Copaxone. Meanwhile, adults treated with Gilenya 0.25mg achieved a numerical risk reduction in relapses compared to the comparator, but did not reach statistical significance.
The safety of Gilenya across both doses was consistent with the known safety profile of the drug. Notably, more discontinuations due to adverse events and unsatisfactory treatment effects were reported in the Copaxone group.
The data from the ASSESS study further reinforces efficacy of Gilenya in treating relapsing MS. The trial was initiated in 2012 as part of a post-approval commitment to the FDA, given the safety concerns regarding MS drugs.
Novartis will complete full analyses of the ASSESS data and plans to submit the results to upcoming medical meetings.
The company’s shares have gained 4.2% in the year so far compared with the industry’s growth of 8.4%.
Novartis’ MS portfolio comprises approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. In Europe, the drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease.
The company has other pipeline candidates like OMB157 (ofatumumab), a fully human monoclonal antibody being evaluated for relapsing MS. Additionally, siponimod, which is 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.
Novartis’ generic division, Sandoz markets Glatopa, a generic version of Copaxone (both 20 and 40 mg), in partnership with Momenta Pharmaceuticals (MNTA - Free Report) .
We note that Biogen, Inc. (BIIB - Free Report) 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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