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[In Context] A resurrection of aducanumab for Alzheimer's disease

06:33 EST 4 Dec 2019 | The Lancet

On Mar 21, 2019, Biogen announced that the anti-amyloid antibody aducanumab failed futility analyses in two identically designed phase 3 Alzheimer's disease trials, and discontinued its development. However, on Oct 22, 2019, Biogen made the surprise announcement that they were applying for US Food and Drug Administration (FDA) marketing approval of aducanumab. The company explained that they reanalysed data from the trials to include patients who had continued in the studies from the Dec 26, 2018, cut-off date for the futility analyses to Mar 21, 2019, when futility was announced.

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