A sign for the Food and Drug Administration is visible in front of the headquarters on July 20, 2020 in White Oak, Maryland.
Sarah Silbiger Getty Images
A third member of a key advisory group on the Food and Drug Administration has resigned over the agency̵
Dr Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the Nutrient Agency’s decision “is perhaps the worst drug approval decision in recent US history”, according to his resignation letter received. from CNBC.
“At the last minute, the agency shifted its review to the path of accelerated approval based on the controversial premise that the drug’s effect on cerebral amyloid is likely to help patients with Alzheimer’s disease,” he wrote, resigning from the FDA’s peripheral and central nervous systems. Advisory Committee.
He writes that it is “clear” to him that the agency is currently unable 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 innovations and the accessibility of the healthcare system,” he said.
Shares of Biogen rose 38 percent 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 nearly two decades.
Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists say plays a role in the devastating disease.
The FDA approved the drug under a program called accelerated approval, which is commonly used for anti-cancer drugs, expecting the drug to slow cognitive decline in Alzheimer’s patients. The Agency granted approval on condition that Biogen conduct another clinical trial.
The agency’s decision deviated from the advice of its independent group of outside experts, who unexpectedly refused to approve the drug last fall, citing unconvincing 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 FDA panel members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and University of Washington neurologist Dr. Joel Perlmutter have also resigned.
“I was very disappointed with the way the advisory committee’s contribution was handled by the FDA,” Knopman told Reuters. “I don’t want to be put in that position again.”
Federal regulators are under strong pressure from friends and family members of Alzheimer’s patients to speed up the use of a drug scientifically known as vivisanumab, but the path to regulatory approval is controversial as it showed promise in 2016.
In March 2019, Biogen stopped developing the drug after an analysis by an independent group revealed that it was unlikely to work. The company then shocked investors a few months later by announcing that it would still seek regulatory approval for the drug.
When Biogen sought approval for the drug at the end of 2019, its researchers said a new analysis of a larger set of data showed that wasvanumab “reduces the clinical decline in patients with early Alzheimer’s disease.”
Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether clinical trial data were enough to prove the drug worked and whether approval could make it harder for other companies to include patients in their own drug trials.
Some doctors have said they will not prescribe obrazovanumab because of the mixed data package that supports the company’s application.
“Reuters contributed to this report.”