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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 resolution to approve Biogen‘s new Alzheimer’s drug, Aduhelm, CNBC has realized.

Dr. Aaron Kesselheim, a professor of medication at Harvard Medical School, mentioned the company’s resolution on Biogen “was probably the worst drug approval decision in recent U.S. history,” based on 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 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% Monday after the FDA accepted the biotech firm’s drug, the primary treatment cleared by U.S. regulators to gradual cognitive decline in individuals residing with Alzheimer’s and the primary new medication for the illness in practically 20 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 referred to as accelerated approval, which is often used for most cancers drugs, 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 resolution 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 referred to as an excessively optimistic evaluate of the info.

At least two different FDA panel members have resigned consequently of the company’s resolution 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,” Dr. Knopman informed Reuters. “I don’t wish to be put in a position like this again.”

–Reuters contributed to this report.

This is a growing story. Please test again for updates.



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