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ALKS : Diroximel Fumarate Shows Superior GI Tolerability On EVOLVE-MS-2 Endpoint

Alkermes plc (ALKS) and Biogen Inc. (BIIB) announced positive results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase 3 study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis or RRMS, compared to TECFIDERA or dimethyl fumarate.

Alkermes noted that Diroximel fumarate demonstrated statistically superior GI tolerability compared to dimethyl fumarate on the EVOLVE-MS-2 study's primary endpoint, as well as a low discontinuation rate of less than 1% due to GI adverse events.

The EVOLVE-MS-2 study is part of the EVOLVE-MS diroximel fumarate clinical development program, which is being conducted as part of a worldwide development and commercialization agreement between Alkermes and Biogen.

Diroximel fumarate is currently under review with the U.S. Food and Drug Administration with a PDUFA (Prescription Drug User Fee Act) target action date in the fourth quarter of 2019. Biogen plans to market diroximel fumarate under the conditionally approved brand name VUMERITY.

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