Aduhelm developers plan phase 4 study

Biogen Inc. and Eisai Co. Ltd. announced plans to submit their phase 4 protocol for Aduhelm to the FDA in March 2022.

The study is a post-marketing requirement following the FDA’s accelerated approval of Aduhelm (aducanumab 100 mg/mL injection, Biogen/Eisai) for treating Alzheimer’s disease and will be a global, placebo-controlled trial, the companies said in a joint press release.

It is expected that approximately 1,300 patients showing early symptoms of Alzheimer’s disease will take part, with an 18-month window between commencement and conclusion of treatment. Biogen and Eisai said in the release that patient screening is expected to begin in May, and the study will last 4 years, with a potential 48-month extension to create longer term data.

“We are delivering on our commitment to accelerate the timelines with the goal to complete the confirmatory study well ahead of schedule,” Priya Singhal, MD, MPH, head of global safety & regulatory sciences and interim head of research & development at Biogen, said in the release. “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.”

Last July, the FDA issued an updated label for Aduhelm, which limited the scope of its use to a certain portion of Alzheimer’s patients included in previous clinical trials.

The companies said they will work with the FDA, external stakeholders and regulators on the design of the upcoming study.