A sign for the Food and Drug Administration is seen outside the headquarters July 20, 2020 in White Oak, Maryland.
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A third member of a key Food and Drug Administration advisory group has resigned following the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, TBEN has learned.
Dr Aaron Kesselheim, professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was possibly the worst drug approval decision in recent US history,” according to his letter. resignation obtained by TBEN.
At the last minute, the agency switched its review to the fast-track approval path on the questionable principle that the drug’s effect on cerebral amyloid was likely to help patients with the disease. Alzheimer’s, ”he wrote in resigning the central and peripheral nervous system from the FDA. Consultative Committee.
He wrote that it was “clear” to him that the agency is not “currently able to adequately incorporate the Committee’s scientific recommendations into its approval decisions.”
“It will undermine the care of these patients, the public’s confidence in the FDA, the pursuit of useful therapeutic innovations and the affordability of the healthcare system,” he said.
Biogen shares jumped 38% on Monday after the FDA approved the biotech company’s drug, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s disease and the first new drug for the disease in nearly two decades.
Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists say plays a role in this devastating disease.
The FDA has approved the drug under a program called Fast Track Approval, which is typically used for cancer drugs, expecting the drug to slow cognitive decline in patients with Alzheimer’s disease. . The agency granted approval on the condition that Biogen conduct another clinical trial.
The agency’s decision deviated from the advice of its independent panel of external experts, who unexpectedly refused to approve the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what they called an overly positive review of the data.
At least two other members of the FDA panel have resigned following the agency’s decision on the drug. Mayo Clinic neurologist Dr David Knopman and University of Washington neurologist Dr Joel Perlmutter also submitted resignation letters.
“I was very disappointed with the way the advisory committee’s contribution was handled by the FDA,” Dr Knopman told Reuters. “I don’t want to be put in a position like this again.”
Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients to urge aducanumab to be ramped up, but the path to regulatory approval has been controversial since it turned out to be promising in 2016.
In March 2019, Biogen halted development of the drug after analysis by an independent group found it unlikely to work. The company then shocked investors several months later by announcing that it would ultimately seek regulatory approval for the drug.
When Biogen applied for drug approval in late 2019, its scientists said that a new analysis of a larger data set showed aducanumab “reduces clinical decline in patients with Alzheimer’s disease. early “.
Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some questioning whether there was enough clinical trial data to prove the drug works and whether approval could make it harder for other companies to list. of patients in their own drug trials.
Some doctors have said they will not prescribe aducanumab due to the mixed data package supporting the company’s claim.
–Reuters contributed to this report.