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Biogen, Eisai To Discontinue Phase 3 ENGAGE, EMERGE Trials Of Aducanumab

Biogen (BIIB) and Eisai, Co., Ltd. announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. As part of the decision, the EVOLVE Phase 2 safety study and the long-term extension of the PRIME Phase1b study of aducanumab will also be discontinued.

Biogen said the decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion.

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