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 medication at Harvard Medical School, mentioned 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.
Evidence to approve of Biogen's Alzheimer's drug was not 'enough,' says Penn's Dr. Jason KarlawishThe News with Shepard Smith
He wrote it was "clear" to him that the company is just not "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 mentioned.
Shares of Biogen surged 38% on Monday after the FDA permitted the biotech firm's drug, the primary treatment 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 count on performs a job within the devastating illness.
The FDA permitted the drug underneath a program known as accelerated approval, which is normally 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 unbiased panel of outdoors consultants, who unexpectedly declined to endorse the drug final fall, citing unconvincing knowledge. At the time, the panel additionally criticized company workers for what it known as an excessively optimistic evaluate of the information.
At least two different FDA panel members have resigned because of this 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 growth of the drug after an evaluation from an unbiased group revealed it was unlikely to work. The firm then shocked traders 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 mentioned a brand new evaluation of a bigger dataset confirmed aducanumab "reduced clinical decline in patients with early Alzheimer's disease."
Alzheimer's consultants and Wall Street analysts have 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 tougher for different firms to enroll sufferers in their very own drug trials.
Some docs have mentioned they gained't prescribe aducanumab as a result of of the blended knowledge package deal supporting the corporate's utility.
– Reuters contributed to this report.
primarily based on website supplies www.cnbc.com