Aduhelm Developers Step Up Phase 4 Confirmatory Study

Aduhelm Developers Step Up Phase 4 Confirmatory Study

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Aduhelm Developers Step Up Phase 4 Confirmatory Study

Biogen and Eisai are stepping up their Phase 4 post-marketing confirmatory study to verify that Aduhelm (aducanumab) is meeting the expected clinical benefit in patients with early-stage Alzheimer’s disease. The companies plan to submit the study’s final protocol for review to the U.S. Food and Drug Administration (FDA) in March. The study will be aiming to enroll more than 1,300 patients globally with early-stage Alzheimer’s, starting in May.  Based on enrollment rates from previous Aduhelm’s Phase…

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