Biogen submits Phase 4 study protocol for Alzheimer's disease drug

Biogen Inc. said Wednesday it submitted the study protocol to the Food and Drug Administration for a confirmatory clinical trial for Aduhelm, its Alzheimer's disease drug. The regulator approved Aduhelm a year ago under the condition that a confirmatory trial would be conducted. Biogen said it expects to complete the placebo-controlled Phase 4 study in four years; the study is designed to enroll 1,500 patients. Biogen's stock has declined 10.4% so far this year, while the broader S&P 500 is 2.8%.

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