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 drugs at Harvard Medical College, mentioned the company’s choice on Biogen “was most likely the worst drug approval choice in latest U.S. historical past,” in accordance with his resignation letter obtained by CNBC.

“On the final minute, the company switched its evaluate to the Accelerated Approval pathway based mostly on the debatable premise that the drug’s impact on mind amyloid was possible 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 permitted the biotech company’s drug, the primary remedy cleared by U.S. regulators to sluggish cognitive decline in individuals residing with Alzheimer’s and the primary new drugs for the illness in almost twenty years.

The company’s choice was a departure from its from the recommendation of its impartial panel of exterior specialists, who unexpectedly declined to endorse the drug final fall, citing unconvincing information. On the time, the panel additionally criticized company employees for what it known as an excessively constructive evaluate of the info.

This can be a growing story. Please test again for updates.

Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

source link Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

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