A third member of a key FDA panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.
A third member of a key Food and Drug Administration advisory panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.
"At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease," he wrote in resigning from the FDA's Peripheral and Central Nervous System Advisory Committee.Evidence to approve of Biogen's Alzheimer's drug was not 'sufficient,' says Penn's Dr.
The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer's patients. The agency granted approval on the condition that Biogen conducts another clinical trial.who unexpectedly declined to endorse
"I was very disappointed at how the advisory committee input was treated by the FDA," Knopman told Reuters. "I don't wish to be put in a position like this again."
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