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Vumerity: New Oral MS Medication FDA-approved

Oct 30 2019

Vumerity is a twice a day oral medication for patients with multiple sclerosis.  The active ingredient of Vumerity is diroximel fumarate, which  is rapidly converted to monomethyl fumarate in the body.  Similarly dimethyl fumarate (Tecfidera) is also converted to monomethyl fumarate.  Therefore, Vumerity would be expected to the same benefits as Tecfidera on multiple sclerosis such as 53% reduction of relapses, 38% reduction in likelihood of disability progression and 90% reduction on active contrast MRI lesions (DEFINE trial).

Full results of the EVOLVE-MS trials are pending including the EVOLVE-MS-1 study, a Phase 3, open-label, two-year safety study and the EVOLVE-MS-2 study, a Phase 3, five-week randomized, prospective, double-blind, multi-center study that assessed the gastrointestinal (GI) tolerability of VUMERITY and TECFIDERA using self-administered GI questionnaires.  Based on preliminary results of EVOLVE-MS-1 study that I presented at ECTRIMS in September 2019, approximately 30% of Vumerity had gastrointestinal side effect but less than 1% discontinue due to this side effect.  Lymphocyte (type of white blood cell) monitor is important to reduce potential risk of PML, a brain viral infection.  Thanks to all of our patients who participated in the clinical trials.

BY: Barry Singer, MD DATE: October 30, 2019 TOPIC: Uncategorized