Biogen Drops Alzheimer’s Drug Aduhelm
- Posted by ISPE Boston
- On February 8, 2024
Biogen has announced plans to reprioritize its resources in Alzheimer’s disease, a strategic therapeutic area expected to drive near and long-term growth. The company will continue to advance Leqembi, 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). At the same time, Biogen will discontinue the development and commercialization of Aduhelm, a decision not related to any safety or efficacy concerns. A large portion of the resources resulting from termination of the Aduhelm program will be redeployed in Biogen’s Alzheimer’s franchise.
“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,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
Biogen began a strategic review of its R&D efforts in early 2023, 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 Aduhelm post-marketing confirmatory clinical study and the likely advancements in the field by the time of potential FDA traditional approval. (Aduhelm received accelerated approval from the FDA in June 2021; the Phase 4 post-marketing confirmatory study was a requirement of the accelerated approval.) Despite an extensive process, the company was unable to identify potential strategic partners or external financing.
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. (Source: Biogen Website, 31 January, 2024)