Biogen and Eisai, Co., Ltd. are discontinuing global Phase III trials, ENGAGE and EMERGE, evaluating the efficacy and safety of aducanumab in mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. The decision 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. The recommendation to stop the studies was not based on safety concerns.

“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience.  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,” said Michel Vounatsos, chief executive officer at Biogen. “Biogen’s history has been based on pioneering innovation, learning from successes and setbacks.  Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”