Pending patent expiration, Alkermes-Biogen MS therapy nears final FDA approval

Alkermes disclosed that FDA has granted tentative approval of Vumerity diroximel fumarate (BIIB098) to treat multiple sclerosis, signaling that full approval could come following the expiration of a patent on Oct. 20.

The company’s partner Biogen Inc. (NASDAQ:BIIB) has commercialization rights to Vumerity, a small molecule prodrug of monomethyl fumarate that would extend Biogen’s MS franchise. Alkermes is eligible to receive a $150 million milestone payment upon Vumerity’s full approval...