practicalneurology.com
Biogen (Cambridge, MA) has canceled the development and commercialization of Aduhelm (aducanumab; Biogen, Cambridge, MA), and is strategically redirecting resources towards other assets in its Alzheimer disease (AD) pipeline, particularly Leqembi (lecanumab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA). In 2021, Aduhelm, an amyloid beta (Aß)-directed monoclonal antibody (mAb), received accelerated approval from the Food and Drug Administration (FDA) as an injection for intravenous (IV) use for the treatment of people with early-stage AD.
The decision to realign resources follows a strategic review of Biogen’s research and development efforts initiated in 2023 and is not based on safety or efficacy concerns. As a result of this decision, Biogen will terminate its planned postmarking confirmatory phase 4 ENVISION clinical trial (NCT05310071). According to a statement from the company, close out costs for the Aduhelm program incurred a one-time charge of approximately $60 million. Biogen has also terminated its license for Aduhelm, reverting rights for the medication back to Neurimmune (Zurich, Switzerland), the company that originally discovered the mAb.
“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,” said Christopher A. Viehbacher, President and CEO of Biogen. “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.”