A impress for the Meals and Drug Administration is seen launch air of the headquarters on July 20, 2020 in White Oak, Maryland.
Sarah Silbiger | Getty Photos
A third member of a key Meals and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen‘s new Alzheimer’s drug, Aduhelm, CNBC has realized.
Dr. Aaron Kesselheim, a professor of medication at Harvard Scientific College, mentioned the agency’s decision on Biogen “develop to be potentially the worst drug approval decision in most up-to-date U.S. historic past,” in response to his resignation letter bought by CNBC.
“On the final minute, the agency switched its evaluate to the Accelerated Approval pathway in step with the debatable premise that the drug’s enact on mind amyloid develop to be likely to abet patients with Alzheimer’s illness,” he wrote in resigning from the FDA’s Peripheral and Central Anxious Machine Advisory Committee.
He wrote it develop to be “definite” to him that the agency is now not “at this time expedient of adequately integrating the Committee’s scientific suggestions into its approval decisions.”
“This is able to presumably well undermine the care of these patients, public belief in the FDA, the pursuit of necessary therapeutic innovation, and the affordability of the effectively being care intention,” he mentioned.
Shares of Biogen surged 38% Monday after the FDA authorized the biotech company’s drug, the well-known medication cleared by U.S. regulators to sluggish cognitive decline in people residing with Alzheimer’s and the well-known new medication for the illness in nearly two a long time.
Biogen’s drug targets a “sticky” compound in the mind usually known as beta-amyloid, which scientists ask plays a feature in the devastating illness.
The FDA authorized the drug below a program known as accelerated approval, which is on the total light for cancer medicines, awaiting the drug would sluggish the cognitive decline in Alzheimer’s patients. The agency granted approval on the condition that Biogen conducts another medical trial.
The agency’s decision develop to be a departure from the recommendation of its impartial panel of launch air specialists, who all today declined to endorse the drug final tumble, citing unconvincing data. On the time, the panel additionally criticized agency workers for what it known as an extraordinarily certain evaluate of the data.
No now not as much as two various FDA panel members beget resigned as a results of the agency’s decision on the drug. Mayo Sanatorium neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter beget additionally submitted resignation letters.
“I develop to be very upset at how the advisory committee enter develop to be treated by the FDA,” Dr. Knopman quick Reuters. “I develop now not uncover to be build in a contrivance handle this again.”
–Reuters contributed to this file.
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