D-Day for Aducanumab — What’s at stake: a BioCentury podcast
All eyes are on FDA as the PDUFA goal approaches for aducanumab, Biogen’s candidate for Alzheimer’s. On the latest BioCentury This Week – Special Edition, BioCentury’s editors discuss how the pending decision could have far-reaching ramifications for the development of therapies regulated by the Office of Neuroscience at FDA’s Center for Drug Evaluation and Research, and how the decision could affect the agency’s reputation.
To say that aducanumab from Biogen Inc. (NASDAQ:BIIB) has had a roller-coaster ride to reach this point would be an understatement, even in its most recent history.
The anti-amyloid therapy failed two Phase III trials for futility in March 2019, only to have Biogen later report that one of the studies, EMERGE, actually met the primary cognitive endpoint, albeit with a large amount of imputed data, Executive Editor Selina Koch notes.
Then at a November 2020 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss a BLA for the therapy, panel members voted 0-10 against the idea that EMERGE alone could reasonably be considered primary evidence of effectiveness of the mAb in light of supporting evidence from other studies.
FDA’s advisers not only roundly rebuffed aducanumab, they also lambasted the agency for bias in its presentation of the analyses. But there’s little doubt that FDA’s Division of Neurology 1 and Billy Dunn, acting director for the Office of Neuroscience, want to approve aducanumab, says Executive Editor Jeff Cranmer.
Washington Editor Steve Usdin addresses a misconception that aducanumab could receive a conditional approval, and discusses why it is crucial for FDA to be thorough and completely transparent in its explanation of its decision, whether positive or negative.
Usdin suggests how the agency could achieve such transparency in an Editor’s Commentary, while an analysis by Koch compares aducanumab’s situation to past products that FDA approved after a negative advisory committee vote.