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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Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is much faster than the nine years required by US FDA under the accelerated approval.
Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is faster than the nine years required by FDA under the accelerated approval.
US FDA cites expected sophistication of specialty prescribers in explaining why a Risk Evaluation and Mitigation Strategy was not needed for the Alzheimer’s drug, even though Biogen had submitted one.