FDA expert panel votes against Biogen’s Alzheimer’s drug, dashing latest hopes for treatment
A panel of independent experts determined that clinical data did not demonstrate enough support to recommend approval of a highly anticipated Alzheimer’s drug. It’s the latest blow to aducanumab, which many believed to be the field’s best shot at federal approval.
The decision was handed down late Friday, after 10 of the 11 U.S. Food and Drug Administration advisory committee members voted that the figures provided by Biogen were not enough to show its drug could alter the progression of Alzheimer’s disease, STAT reported. One member voted “uncertain.”
Alzheimer’s Association President and CEO Harry Johns sent an update to members late Friday afternoon expressing the organization’s frustration with the group's conclusion. Johns claimed the publicly released data justified FDA approval and vowed to continue advocating for aducanumab.
“I am disappointed to report that a FDA advisory committee recommended … that a new drug not be approved by the FDA to treat Alzheimer’s,” he said in the email announcement. “This is not the end of the road. It is one step in the FDA review process.”
Federal regulators do not always base final decisions on the recommendations of FDA independent committees, and is expected to make a determination early next year, according to the Alzheimer’s Drug Discovery Foundation. If given the greenlight, aducanumab would become the first FDA-approved drug to modify the course of AD and slow cognitive decline.
Biogen, whose shares were temporarily suspended during the meeting, released its own statement on Friday.
“Biogen thanks the many patients and advocates who shared their personal thoughts and experience at today’s advisory committee meeting, reflecting the significant unmet need for a treatment for Alzheimer’s,” Michel Vounatsos, Biogen’s CEO, said on Nov. 6. “We appreciated the opportunity to share our data with the advisory committee, and we will continue to work with the FDA as it completes its review of our application.”
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.