Aducanumab is an amyloid beta-directed monoclonal antibody that received accelerated FDA approval in 2021 for Alzheimer's disease based on amyloid plaque reduction as a surrogate endpoint. Biogen announced in January 2024 that it would discontinue development and commercialization of Aduhelm and terminate the required confirmatory ENVISION study for strategic portfolio reasons. The product is therefore not in active commercial development by Biogen.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
A review of 17 studies involving 20,342 patients found anti-amyloid Alzheimer’s drugs had “trivial” effects after 18 months and increased the risk of brain swelling and bleeding. A separate PET study suggested ARIA-E may mark brain regions with greater amyloid plaque reduction.
