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3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals

 
• By Sue Sutter

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.

Runway
The runway is long for the aducanumab confirmatory trial. • Source: Alamy

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.

Under fire for the length of time provided to design and conduct a new Phase IV study to confirm the drug’s clinical benefit, the agency vowed it would push for interim analyses while the trial is ongoing, and Biogen said it is

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