Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug
An indication for the Meals and Drug Administration is seen exterior of the headquarters on July 20, 2020 in White Oak, Maryland.
Sarah Silbiger | Getty Photos
A 3rd member of a key Meals and Drug Administration advisory panel has resigned over the company‘s controversial choice to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has realized.
Dr. Aaron Kesselheim, a professor of medication at Harvard Medical College, mentioned the company‘s choice on Biogen “was in all probability the worst drug approval choice in current U.S. historical past,” in response to his resignation letter obtained by CNBC.
“On the final minute, the company switched its assessment to the Accelerated Approval pathway based mostly on the debatable premise that the drug’s impact on mind amyloid was seemingly to assist sufferers with Alzheimer’s illness,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.
Shares of Biogen surged 38% Monday after the FDA authorized the biotech firm’s drug, the primary medicine cleared by U.S. regulators to gradual cognitive decline in individuals residing with Alzheimer’s and the primary new medication for the illness in practically twenty years.
The company‘s choice was a departure from its from the recommendation of its unbiased panel of outdoor consultants, who unexpectedly declined to endorse the drug final fall, citing unconvincing knowledge. On the time, the panel additionally criticized company employees for what it known as an excessively constructive assessment of the info.
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