Free Access To High-Cost Aducanumab May Incentivize Phase IV Trial Participants

Accelerated Approval Adds Another Alzheimer’s Study To Global Pipeline

Experts say there should be enough Alzheimer’s patients willing to enroll in Biogen/Eisai’s US FDA-required Phase IV trial and other companies’ late-stage studies even with Aduhelm broadly available.

Senior patient listens to his doctor — The confirmatory trial for Aduhelm also is likely to enroll a significant number of ex-US patients • Source: Alamy

The requirement for Biogen, Inc. and Eisai Co., Ltd. to conduct a Phase IV clinical trial as a condition of Aduhelm’s accelerated approval raises the question of whether Alzheimer’s disease patients in the US will be willing to enroll in the trial – or in other companies’ large, late-stage studies – when the drug is broadly available following its 7 June US Food and Drug Administration approval.

However, experts who spoke with Scrip about the agency’s Aduhelm (aducanumab) decision noted that with millions of people diagnosed with...