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Alkermes' (ALKS) and Biogen's NDA for BIIB098 Accepted by FDA

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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.

Zacks Rank

Alkermes 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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