The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a novel oral fumarate candidate, diroximel fumarate (Alkermes and Biogen), for the treatment of relapsing forms of multiple sclerosis (MS).

Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body, the active metabolite of dimethyl fumarate (Tecfidera; Biogen). Due to its chemical properties, it has the potential for improved gastrointestinal (GI) tolerability when compared with dimethyl fumarate.

The NDA is supported by data from a phase 3, open-label, 2-year safety study (EVOLVE-MS-1) which showed that treatment with diroximel fumarate was associated with low rates of GI adverse events leading to discontinuation. A head-to-head GI tolerability study (EVOLVE-MS-2) vs dimethyl fumarate is also being conducted with results expected later this year.

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Biogen is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, an abbreviated approval pathway that allows for some of the information required for approval to come from studies related to dimethyl fumarate. A Prescription Drug User Fee Act target date for the NDA has been set for the fourth quarter of 2019. If approved, Biogen plans to market the drug under the brand name Vumerity.  

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