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 . However, on Oct 22, 2019, Biogen made the surprise announcement that they were 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. Biogen stated that one trial showed significant findings and a subset from the second trial supports these positive findings. At a on Nov 21, 2019, Biogen challenged the FDA not to approve aducanumab now, stating that they should not be required to do another trial.

中文翻译：

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阿德那单抗对阿尔茨海默氏病的复活。

在2019年3月21日，Biogen宣布抗淀粉样蛋白抗体aducanumab在两项相同设计的3期阿尔茨海默氏病试验中无效试验无效，并且。然而，在2019年10月22日，百健公司意外宣布其已获得美国食品药品监督管理局（FDA）批准aducanumab的市场批准。该公司解释说，他们重新分析了该试验的数据，以纳入从2018年12月26日（无效性分析的截止日期）到2019年3月21日（宣布无效性）之后继续进行研究的患者。Biogen表示，一项试验显示出重要的发现，而第二项试验的一部分支持了这些积极的发现。在2019年11月21日的一次，Biogen要求FDA现在不要批准aducanumab，指出不应要求他们进行另一项试验。