Biogen and Eisai Halt Phase 3 Trials Testing Aducanumab for Early Alzheimer’s

Biogen and Eisai Halt Phase 3 Trials Testing Aducanumab for Early Alzheimer’s
Two Phase 3 clinical trials testing the investigational therapy aducanumab in patients with early Alzheimer’s disease have been discontinued. Biogen and Eisai came to this decision after an analysis from an independent data monitoring committee indicated that the global ENGAGE (NCT02477800) and EMERGE (NCT02484547) studies of aducanumab were unlikely to meet their primary objectives. The recommendation to discontinue the trials was not based on safety concerns, according to the companies. “This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,” Michel Vounatsos, Biogen’s CEO, said in a press release. “We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research." Vounatsos also said that Biogen will continue advancing its pipeline of treatment candidates in Alzheimer’s and other diseases of high unmet need. The two trials were evaluating the efficacy and safety of two doses of aducanumab in people with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia. The primary objective of the randomized and do
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