Biogen announces discontinuation of Aduhelm
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Biogen announced a reprioritization of resources regarding its pipeline of therapeutics to address Alzheimer’s disease, deciding to discontinue development of Aduhelm and choosing to advance Leqembi.
According to a company release, Biogen will cease commercialization of Aduhelm in its 100 mg/mL IV formulation and will also end the ENVISION clinical study, a decision that Biogen said was unrelated to concerns about safety or efficacy. A significant portion of resources from the program termination will be placed back into Biogen’s AD franchise, the company additionally stated.
“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,” Christopher A. Viehbacher, president and CEO of Biogen, stated in the release. “When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed.”
Biogen sought both partners and external financing for further development of Aduhelm beginning in January 2023, but during the extensive review and search process, could not identify either to satisfy their goals.
Aduhelm received accelerated approval from the FDA in June 2021, and the subsequent phase 4 ENVISION study was a requirement of that approval.
Biogen has recorded a one-time charge of approximately $60 million in close-out costs for the program. Biogen licensed Leqembi from Neurimmune and has terminated that license, with rights also reverting to Neurimmune.
Eisai currently heads the effort to develop Leqembi globally, whereas Eisai and Biogen jointly lead commercialization and promotion for the product and Eisai holds the final decision-making authority.
“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,” Priya Singhal, MD, MPH, head of development at Biogen, said in the release. “We’d like to sincerely thank the trial investigators, health care providers, advocates, patients and families involved in the development of Aduhelm.”