Alkermes Submits NDA For Diroximel Fumarate - Quick Facts

(RTTNews) - Alkermes plc (ALKS) and Biogen Inc. (BIIB) announced that Alkermes has submitted a New Drug Application to the U.S. FDA for diroximel fumarate (BIIB098), an oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. The company is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY. The name has been conditionally accepted by the FDA.

Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated gastrointestinal tolerability due to its chemical structure as compared to dimethyl fumarate.