An indication for the Food and Drug Administration is seen outdoors of the headquarters on July 20, 2020 in White Oak, Maryland.
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A 3rd member of a key Food and Drug Administration advisory panel has resigned over the company’s controversial choice to approve Biogen‘s new Alzheimer’s drug, Aduhelm, CNBC has discovered.
Dr. Aaron Kesselheim, a professor of drugs at Harvard Medical School, stated the company’s choice on Biogen “was probably the worst drug approval decision in recent U.S. history,” in line with his resignation letter obtained by CNBC.
“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.
He wrote it was “clear” to him that the company isn’t “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”
“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he stated.
Shares of Biogen surged 38% on Monday after the FDA accepted the biotech company’s drug, the primary medicine cleared by U.S. regulators to gradual cognitive decline in individuals dwelling with Alzheimer’s and the primary new medication for the illness in almost twenty years.
Biogen’s drug targets a “sticky” compound within the mind referred to as beta-amyloid, which scientists anticipate performs a job within the devastating illness.
The FDA accepted the drug beneath a program known as accelerated approval, which is often used for most cancers medicines, anticipating the drug would gradual the cognitive decline in Alzheimer’s sufferers. The company granted approval on the situation that Biogen conducts one other medical trial.
The company’s choice was a departure from the recommendation of its impartial panel of out of doors specialists, who unexpectedly declined to endorse the drug final fall, citing unconvincing knowledge. At the time, the panel additionally criticized company employees for what it known as a very optimistic evaluation of the info.
At least two different FDA panel members have resigned because of the company’s choice on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter have additionally submitted resignation letters.
“I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman instructed Reuters. “I don’t wish to be put in a position like this again.”
Federal regulators have confronted intense stress from family and friends members of Alzheimer’s sufferers asking to fast-track the drug, scientifically referred to as aducanumab, however the street to regulatory approval has been a controversial one because it confirmed promise in 2016.
In March 2019, Biogen pulled improvement of the drug after an evaluation from an impartial group revealed it was unlikely to work. The firm then shocked buyers a number of months later by saying it might search regulatory approval for the drug in spite of everything.
When Biogen sought approval for the drug in late 2019, its scientists stated a brand new evaluation of a bigger dataset confirmed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”
Alzheimer’s specialists and Wall Street analysts had been instantly skeptical, with some questioning whether or not the medical trial knowledge was sufficient to show the drug works and whether or not approval might make it more durable for different corporations to enroll sufferers in their very own drug trials.
Some medical doctors have said they won’t prescribe aducanumab due to the blended knowledge package deal supporting the corporate’s software.
– Reuters contributed to this report.