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Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval

 
• By Sue Sutter

June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.

Aduhelm: One Year Later
• Source: Shutterstock

One year after the US Food and Drug Administration’s accelerated approval of Biogen, Inc.’s Aduhelm (aducanumab-avwa), the Alzheimer’s treatment remains a hot and divisive topic in drug development circles.

Reflecting back on the controversy, it appears the approval and the following pricing and reimbursement decisions could have long-lasting implications, including how the public views the FDA’s role as the arbiter of drug safety and efficacy, how the FDA uses the

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