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...
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