Biogen reprioritizes Alzheimer’s disease resources, discontinues ADUHELM development

Biogen Inc. (Nasdaq: BIIB), a leading pharmaceutical company, today announced a strategic reprioritization of its resources in Alzheimer’s disease (AD), a key therapeutic area expected to drive growth in both the near and long term. The company is set to continue advancing LEQEMBI (lecanemab-irmb), the first anti-amyloid beta treatment with FDA traditional approval in the United States, and will accelerate the development of potential new treatment modalities. These include its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).

In a significant shift, Biogen 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 reportedly not due to any safety or efficacy concerns. Resources from the terminated ADUHELM program will be redeployed to bolster Biogen’s AD franchise.

Christopher A. Viehbacher, President and CEO of Biogen, stated: “As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs. We plan to further advance the launch of LEQEMBI, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline.”

Biogen Enhances Alzheimer’s Disease Franchise, Focusing on LEQEMBI and Innovative Treatments

In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM. The company did not identify potential strategic partners or external financing after an extensive process. Biogen has recorded a one-time charge of approximately $60 million related to closeout costs for the program in the fourth quarter of 2023 and has terminated its license with Neurimmune, with the rights to aducanumab reverting to Neurimmune.

Dr. Priya Singhal, Head of Development at Biogen, commented: “We have gained significant insight from the development of ADUHELM and will carry this forward as we continue our pioneering work in Alzheimer’s disease.” Biogen expressed gratitude to all involved in the development of ADUHELM and acknowledged Neurimmune’s scientific contributions over many years.

ADUHELM received accelerated approval from the U.S. Food and Drug Administration in June 2021, with the Phase 4 post-marketing confirmatory ENVISION study being a requirement of this approval.

Eisai serves as the lead in LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen commercializing and co-promoting the product. Eisai holds final decision-making authority.

Biogen Inc.’s strategic shift in Alzheimer’s disease treatment reflects a focus on advancing newer, potentially more effective treatment modalities. This pivot towards LEQEMBI and other innovative therapies may set a new direction in Alzheimer’s research, offering hope for more effective management of this neurodegenerative disease.