A Food and Drug Administration sign is seen outside their headquarters on July 20, 2020 in White Oak, Maryland.
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A third member of the Food and Drug Administration’s key advisory board has resigned because of the agency’s conflicting decision to approve Biogen̵7;s new Alzheimer’s drug, Aduhelm.
Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “may be the worst recent drug approval decision in US history,” according to his resignation letter obtained by CNBC.
“At the last minute The agency has turned the review into an accelerated approval approach. This is based on the controversial hypothesis that the drug’s effects on amyloids in the brain might help people with Alzheimer’s disease,” he wrote in the FDA’s resignation from the Peripheral and Central Nervous System. Advisory Committee.
He wrote that it was “clear” to him that the agency could not “Currently enough, the committee’s scientific recommendations can be included in the approval decision.”
“This will undermine the care of these patients. Public confidence in the FDA The pursuit of innovative, useful treatments and affordability of the healthcare system,” he said.
Biogen shares rose 38 percent Monday after the FDA approved the biotech company’s drug. First drug to be approved by US regulators to slow cognitive decline in people with Alzheimer’s disease and a new drug for the disease in nearly two decades.
Biogen’s drug targets a “sticky” compound in the brain called beta-amyloid. which scientists expect will play a role in serious disease.
The FDA approves the drug under a program known as accelerated approval. which is often used for cancer drugs The drug is thought to slow cognitive decline in Alzheimer’s patients. The agency approved on condition that Biogen is conducting another clinical trial.
This agency’s decision is a departure from the recommendation of an independent committee of external experts. who unexpectedly declined to endorse the drug last fall. citing unreliable data. At the time, the committee also criticized agency officials for what it called an excessive review of positive data.
At least two other FDA board members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neuroscientist Dr. Joel Perlmutter also sent their resignation letters.
“I am very disappointed with the way the FDA treats advisory board data,” Dr. Knopman told Reuters. “I don’t want to be positioned like this again.”
–Reuters contributed to this report.
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