The US Food and Drug Administration and Biogen, Inc. have been on the defensive over the nearly nine-year timeline the company has in which to complete the confirmatory trial for Aduhelm (aduncaumab-avwa), the Alzheimer’s drug that received a controversial accelerated approval on 7 June.
3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.
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