Biogen completes U.S. application for Alzheimer’s drug aducanumab

Despite uneven results from late-stage clinical trials, Biogen (NASDAQ:BIIB) announces that it has completed the submission of its U.S. marketing applicati Continue reading on Seeking Alpha

Despite uneven results from late-stage clinical trials, Biogen (NASDAQ:BIIB) announces that it has completed the submission of its U.S. marketing application seeking approval of aducanumab for Alzheimer’s disease (AD). It has requested Priority Review of the filing.

In March 2019, the company and development partner Eisai terminated two Phase 3 studies in AD patients with mild cognitive impairment after a futility analysis showed that the trials were unlikely to meet the primary endpoints. In December 2019, one of the studies, EMERGE, gave Biogen renewed hope when the high-dose arm met the primary endpoint. The other Phase 3, ENGAGE, failed to achieve the primary and secondary endpoints in both the low-dose and high-dose arms.

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