EMA’s CHMP backs Biogen’s ALS drug and an IgAN therapy from CSL, Travere

In its February meeting, EMA’s CHMP recommended approval of seven new medicines, including Qalsody and Filsapri, and label extensions for six approved therapies. 

CHMP has agreed with FDA that the data supporting Qalsody tofersen from Biogen Inc. (NASDAQ:BIIB), while not comprehensive, is sufficient to allow marketing for SOD1-mutant amyotrophic lateral sclerosis (ALS). The agency is evaluating Qalsody under the exceptional circumstances pathway due to the rarity of the SOD1 subset of ALS,  which accounts for about 2% of an already rare disease. FDA granted accelerated approval to the drug in April 2023 based on NfL as a surrogate endpoint. ...