Update on the phase IV confirmatory study of Aduhelm for Alzheimer’s disease – Biogen + Eisai
Biogen Inc. and Eisai Co., Ltd. provided an important update on the continuing progress of the Phase IV post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease.
The companies anticipate submitting the final protocol for review to the FDA in March 2022, with the initiation of patient screening in May 2022. The study is a post-marketing requirement of the FDA’s accelerated approval and will be a global, placebo-controlled trial, aiming to enroll more than 1,300 early Alzheimer’s disease patients, with a primary clinical endpoint at 18 months after treatment initiation. Based on enrollment rates from the previous Phase III trials with Aduhelm, the primary completion date is expected to be approximately four years after the study begins. The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.