Alkermes Plc ALKS and partner Biogen Inc. BIIB announced that the FDA has accepted for review the new drug application (NDA) for diroximel fumarate (BIIB098), the novel oral fumarate, which has been developed for the treatment of relapsing forms of multiple sclerosis (MS). The FDA has set an action date in the fourth quarter of 2019.If approved, Biogen and Alkermes plan to market diroximel fumarate under the brand name Vumerity.
The NDA was submitted in December 2018 and was supported by data from EVOLVE-1, a phase III study that evaluated long-term safety of diroximel fumarate in relapsing-remitting MS (RRMS) in about 700 patients. Further, Alkermes is also conducting the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal (GI) tolerability study evaluating diroximel fumarate versus dimethyl fumarate.
Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated GI tolerability due to its chemical structure as compared to dimethyl fumarate.
MS is a crowded market, with many companies already having drugs in their portfolio approved for this indication. Biogen holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals TEVA has long been in the MS market through its widely used drug Copaxone, which is facing stiff generic competition for the past few years.
Novartis’ NVS MS portfolio comprises approved drugs like Gilenya and Extavia for the treatment of relapsing forms of MS.
Alkermes currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Novartis AG (NVS) : Free Stock Analysis Report
Alkermes plc (ALKS) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report
To read this article on Zacks.com click here.