In their decision to approve aducanumab for the treatment of patients with Alzheimer's disease, the US Food and Drug Administration (FDA) mandated a post-approval study to confirm the anticipated clinical benefit for the drug. On 16 December, Biogen and Eisai announced plans to launch its Phase 4 confirmatory study of aducanumab in May 2022.
The new study will be a global, placebo-controlled trial, aiming to enroll over 1,300 participants with mild cognitive impairment or mild Alzheimer's dementia. Participants will receive monthly intravenous infusions of aducanumab (100mg/mL), a monoclonal antibody that is directed against amyloid beta, which accumulates in plaques within the brain during the development of Alzheimer's disease. The Phase 4 trial will have a primary clinical endpoint at 18 months, but will also collect longer-term data for up to 48 months.
Biogen and Eisai hope to complete the trial within 4 years, with final results expected in 2026.
https://investors.biogen.com/news-releases/news-release-details/update-phase-4-confirmatory-study-aduhelmr
