Benzinga | Dec 16, 2021 07:05AM EST

Biogen Announces Update On The Phase 4 Confirmatory Study Of ADUHELM

Biogen Inc. (NASDAQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today provided an important update on the continuing progress of the Phase 4 post-marketing confirmatory study of ADUHELM(r) (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer's disease.

The companies anticipate submitting the final protocol for review to the U.S. Food and Drug Administration (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 3 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.

"We are delivering on our commitment to accelerate the timelines with the goal to complete the confirmatory study well ahead of schedule," said Priya Singhal M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. "Together with EMBARK, Biogen's redosing study, and the ICARE AD study, we aim to provide data from real-world practice and clinical trials to further inform patient and physician decisions about treatment."

"I am very encouraged by this update and Biogen's and Eisai's goal to complete the trial in four years after its initiation, approximately half of the time that the FDA provided as part of the accelerated approval," said Marwan Sabbagh, M.D., FAAN, Professor of Neurology, Alzheimer's and Memory Disorders Division, Barrow Neurological Institute. "This is a significant commitment from the companies. It takes time to execute a complex, global trial of this nature, so I am pleased to see the high level of priority being afforded to this study."

The companies will continue to work with FDA, external stakeholders and regulators in other geographies on the study design.