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Biogen and Eisai discontinue Phase III ENGAGE and EMERGE studies of aducanumab

Thursday 21 March 2019

 On 21 March, the pharmaceutical companies Biogen and Eisai announced the decision to discontinue the ENGAGE and EMERGE Phase III studies of aducanumab in Alzheimer’s disease (AD).

ENGAGE and EMERGE are Phase III multicenter, randomised, double-blind, placebo-controlled and parallel-group studies designed to evaluate the efficacy and safety of aducanumab in people with mild cognitive impairment due to AD and mild AD dementia.

The decision to halt the trials is based on results from a futility analysis conducted by an independent data monitoring committee, which reported that the trials were unlikely to meet their primary endpoint in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score upon completion. Detailed data from the ENGAGE and EMERGE studies will be presented at future meetings.

As a result of this decision, the EVOLVE Phase II safety study and the PRIME Phase Ib long-term extension study of aducanumab will also be discontinued.