CHMP opinions for September: Data Byte

CHMP has recommended approval of five new therapies and indication expansions for nine.

Among the recommendations for new approvals is multiple sclerosis candidate Vumerity diroximel fumarate from Biogen Inc. (NASDAQ:BIIB), which was approved by FDA in 2019 and quickly criticized for its high cost. The therapy still has a long way to go to catch market-leaders such as Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY), but Biogen said in its 2020 annual report that Vumerity was the number two MS product and the number one oral MS product in new prescriptions in the U.S. at the end of 2020. Biogen’s Tecfidera dimethyl fumarate has been losing ground to generic competition. ...