BioCentury
ARTICLE | Regulation

FDA reviewing Biogen’s ALS candidate, opening door for neurofilament as biomarker

Advisory committee to discuss application for tofersen’s accelerated approval for subset of ALS patients despite missed primary endpoint in pivotal trial

July 26, 2022 11:43 AM UTC

FDA will for the first time consider a surrogate endpoint evaluating neurofilament light chain biomarker results as part of the data package in an NDA seeking accelerated approval of Biogen’s tofersen to treat a subset of ALS patients.

Biogen Inc. (NASDAQ:BIIB) said Tuesday that FDA granted tofersen (BIIB067) priority review to treat amyotrophic lateral sclerosis associated with mutations in SOD1, representing about 2% of the disease’s overall population. Its PDUFA date is Jan. 25, 2023; Biogen expects FDA to convene an advisory committee during the review to discuss accelerated approval...

BCIQ Company Profiles

Biogen Inc.