The investigational drug diroximel fumarate (Vumerity, Biogen/Alkermes) showed statistically superior gastrointestinal (GI) tolerability compared with dimethyl fumarate (Tecfidera, Biogen) in patients ...

DUBLIN and CAMBRIDGE, Mass., July 30, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced positive topline results from EVOLVE-MS-2, a large, randomized, ...

The appraisal committee considered evidence submitted by Biogen, a review of this submission by the evidence review group (ERG), and responses from stakeholders. See the committee papers for full ...

(RTTNews) - 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 ...

The FDA today approved Biogen and Alkermes’ diroximel fumarate, an oral agent, to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, ...

Please provide your email address to receive an email when new articles are posted on . Researchers compared data from those treated in the phase 3 EVOLVE-MS-1 and DECIDE studies. Treatment with ...

SEATTLE — The experimental drug diroximel fumarate ([DRF]; Vumerity, Biogen and Alkermes) shows benefits in the treatment of relapsing forms of multiple sclerosis (MS) similar to dimethyl fumarate ...

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Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the NDA submission includes data from EVOLVE-1, a phase 3 pivotal trial that evaluated long-term safety ...

"The FDA's approval of VUMERITY delivers on Biogen's commitment to pursue new therapies that may provide meaningful impact for people living with relapsing MS, and we look forward to bringing it to ...

Please provide your email address to receive an email when new articles are posted on . Relapse rates at 1 and 2 years were smaller among adults with MS on diroximel fumarate vs. dimethyl fumarate.

1.2 If patients and their clinicians consider diroximel fumarate to be one of a range of suitable treatments (including dimethyl fumarate), choose the least expensive treatment, taking into account ...