Biogen has decided to discontinue the development and commercialization of Aduhelm® (aducanumab-avwa), an amyloid beta-directed antibody indicated for the treatment of Alzheimer disease.
Aduhelm received accelerated approval from the Food and Drug Administration (FDA) for this indication in 2021. In a company press release, Biogen stated that resources allocated to the Aduhelm program would instead be put toward advancing the development of another anti-amyloid beta treatment, Leqembi® (lecanemab-irmb), as well as other new treatment modalities. Leqembi received traditional approval from the FDA in 2023 for the treatment of Alzheimer disease in patients with mild cognitive impairment or mild dementia stage of the disease, the population in which treatment was indicated in clinical trials.
According to the Company, the decision to discontinue Aduhelm was not related to any safety or efficacy concerns. The ENVISION study (ClinicalTrials.gov Identifier: NCT05310071), which was expected to verify the clinical benefit of Aduhelm, has also been terminated.
Commenting on the decision, Christopher A. Viehbacher, President and CEO of Biogen, said, “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.”
This article originally appeared on MPR
References:
Biogen to realign resources for Alzheimer’s disease franchise. News release. Biogen. January 31, 2024. https://investors.biogen.com/news-releases/news-release-details/biogen-realign-resources-alzheimers-disease-franchise.