Biogen Inc. announced plans to reprioritize its resources in Alzheimer?s disease (AD), a strategic therapeutic area expected to drive near and long-term growth. The company will continue to advance LEQEMBI® (lecanemab-irmb), the first anti-amyloid beta treatment with FDA traditional approval in the United States, and will accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). The company will discontinue the development and commercialization of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study.

This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen?s AD franchise. In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM, as part of a focus on prioritizing the company?s portfolio.

During this process, 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. Biogen has 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 has terminated that license. The rights to aducanumab will revert to Neurimmune. ADUHELM received accelerated approval from the U.S. Food and Drug Administration in June 2021.

The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of ADUHELM. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen commercializing and co-promoting the product and Eisai having final decision-making authority. BIIB080 is licensed from Ionis.