Biogen discontinues controversial Aduhelm

Feb. 1, 2024

Biogen, in a plan to "reprioritize its resources in Alzheimer’s disease," will discontinue its Aduhelm program.

The drugmaker says it will halt the development and commercialization of the contravesial drug, as well as terminate the post-marketing confirmatory ENVISION study. The resources will then be redeployed back into Biogen's Alzheimer’s franchise. 

Biogen says the Aduhelm decision is strategic, and not related to any safety or efficacy concerns. "Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential Aduhelm FDA traditional approval. Despite an extensive process, the company did not identify potential strategic partners or external financing," the company said in a press release.

The realignment means the Biogen will continue to advance Leqembi, its anti-amyloid beta treatment for Alzheimer’s that won full FDA approval in July 2023. The drugmaker will also accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). 

The writing has been on the wall for Aduhelm after a rocky approval journey, unfavorable national coverage policies in the U.S., and Biogen calling it quits on an observational trial. Back in 2022, Biogen wrote off the remaining inventory.