Biogen Gives Up On Aduhelm Efforts After Two Years Of Controversial FDA Accelerated Approval For Alzheimer's, Shifts Focus On Newer Medicines

Biogen Inc BIIB is pulling the plug on its Aduhelm Alzheimer’s disease drug more than two years after the drug came into the limelight after receiving controversial FDA approval.

Biogen said on Wednesday it would discontinue developing and commercializing Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use and terminate the ENVISION clinical study. 

Related: Slow Market Penetration For Biogen’s Another Alzheimer’s Drug: UBS Highlights Risks, Forecasts.

Aduhelm received accelerated FDA approval in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of Aduhelm.

The company added that the decision was not related to any safety or efficacy concerns. A large portion of the resources released resulting from the termination of the Aduhelm program will be redeployed in Biogen’s Alzheimer’s disease franchise.

Biogen will focus on Leqembi (lecanemab-irmb), its Eisai Ltd.-partnered first anti-amyloid beta treatment with FDA traditional approval in the U.S, and will accelerate the development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).

BIIB080 is licensed from Ionis Pharmaceutical Inc IONS.

Biogen recorded a one-time charge of approximately $60 million related to close-out costs for the program in the fourth quarter of 2023. Biogen licensed aducanumab from Neurimmune and terminated that license. The rights to aducanumab will revert to Neurimmune.

In its second quarter earnings release, Christopher Viehbacher, president and CEO, said, “We have taken a bottom-up view to shift our resources… While we will be making significant investments in our newly prioritized pipeline and new product launches, we will also need to invest less in other areas which are no longer growing.”

Price Action: BIIB shares are up 0.81% at $249.07 at publication Wednesday.