A sign for the Food and Drug Administration will be seen outside headquarters on July 20, 2020 in White Oak, Maryland.
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A third member of a central advisory panel for the Food and Drug Administration has been withdrawn due to the agency̵
Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter from CNBC.
“At the last minute, the agency shifted its review to the accelerated approval pathway based on the questionable assumption that the drug’s effect on brain amyloid would likely help patients with Alzheimer’s disease,” he wrote as he resigned from the FDA’s peripheral and central nervous system. Advisory Committee.
He wrote that it was “clear” to him that the Agency was not “currently able to adequately integrate the Committee’s scientific recommendations into its approval decisions.”
“This will undermine the care of these patients, public confidence in the FDA, the pursuit of useful therapeutic innovation, and the affordability of healthcare,” he said.
Biogen’s share rose 38% Monday after the FDA approved the drug for the biotechnology company, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new drug for the disease in nearly two decades.
The biogenic drug is targeted at a “sticky” compound in the brain known as beta-amyloid, which researchers expect to play a role in the devastating disease.
The FDA approved the drug under a program called accelerated approval, which is commonly used for cancer drugs and expects the drug to slow the cognitive decline in Alzheimer’s patients. The Agency approved on the condition that Biogen conduct another clinical trial.
The agency’s decision was a departure from the advice of its independent panel of external experts, who unexpectedly refused to approve the drug last fall and did not cite convincing data. At the time, the panel also criticized the agency’s staff for what it called an overly positive review of the data.
At least two other members of the FDA panel have withdrawn as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter has also submitted resignation letters.
“I was very disappointed with how the advisory committee’s input was handled by the FDA,” Knopman told Reuters. “I do not want to be put in a position like this again.”
Federal regulators have been under intense pressure from friends and family members of Alzheimer’s patients asking for trace of the drug, scientifically known as aducanumab, but the path to regulatory approval has been controversial since it showed promise in 2016.
In March 2019, Biogen withdrew the development of the drug after an analysis by an independent group revealed that it was unlikely to work. The company then shocked investors several months later by announcing that it would seek approval of the drug after all.
When Biogen sought approval for the drug in late 2019, the researchers said a new analysis of a larger dataset showed that aducanumab “reduced clinical decline in patients with early-onset Alzheimer’s disease.”
Alzheimer’s experts and Wall Street analysts were immediately skeptical, and some wondered if the clinical trial data were sufficient to prove the drug worked and whether approval could make it more difficult for other companies to enroll patients in their own drug trials.
Some doctors have said they will not prescribe aducanumab because of the mixed data package that supports the company’s application.
– Reuters contributed to this report.