Biogen Submits Final Protocol for Phase 4 Aduhelm Study to FDA

Biogen, the co-developer of Aduhelm (aducanumab) has submitted the final protocol for ENVISION — the Phase 4 post-marketing study of the therapy in early Alzheimer’s disease — to the U.S. Food and Drug Administration (FDA) for review and approval, the company has announced. Screening of the first patient is expected in May, according to Biogen’s press release. The study will be completed within about four years. The placebo-controlled ENVISION trial was a requirement by the FDA…

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