Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

An FDA signal is seen exterior the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Selbiger | Getty Photos

CNBC has realized {that a} third member of the FDA’s most important advisory committee has resigned over the company’s controversial resolution to approve Biogen’s new Alzheimer’s drug, Aduhelm.

Dr. Aaron Kesselheim, professor of drugs at Harvard Medical Faculty, mentioned the company’s resolution on Biogen “could have been the worst drug approval resolution in latest U.S. historical past,” in accordance with his resignation letter obtained by CNBC.

“On the final minute, the company shifted its assessment to the accelerated approval pathway based mostly on the debatable premise that the drug’s impact on amyloid within the mind is probably going to assist Alzheimer’s sufferers,” he wrote in his resignation from the FDA’s Central and Peripheral Nervous System. Advisory Committee.

He wrote that it was “apparent” to him that the company “isn’t at the moment in a position to adequately combine the committee’s scientific suggestions into its approval selections.”

“It’s going to undermine the care of those sufferers, the general public’s belief within the Meals and Drug Administration, the pursuit of helpful remedy innovation, and the affordability of the well being care system,” he mentioned.

Shares of Biogen rose 38% Monday after the Meals and Drug Administration authorised the biotech firm’s drug, the primary drug authorised by US regulators to gradual cognitive decline in folks with Alzheimer’s illness and the primary new drug for the illness in practically 20 years.

Biogen targets a “sticky” compound within the mind often called beta-amyloid, which scientists speculate performs a job within the devastating illness.

The Meals and Drug Administration authorised the drug beneath a program referred to as Expedited Approval, which is often used for most cancers medication, and it’s anticipated that the drug will gradual cognitive decline in Alzheimer’s sufferers. The company granted approval on the situation that Biogen conduct one other medical trial.

The company’s resolution was a departure from the recommendation of its unbiased staff of outdoor specialists, who unexpectedly declined to approve the drug final fall, citing unconvincing information. On the time, the committee additionally criticized company staff for what it referred to as a very optimistic assessment of the info.

At the very least two FDA panel members have resigned because of the company’s resolution on the drug. Mayo Clinic neurologist Dr. David Knopman and College of Washington neurologist Dr. Joel Perlmutter have additionally submitted letters of resignation.

“I used to be very dissatisfied in the best way the FDA dealt with the advisory committee’s contributions,” Dr. Knopman informed Reuters. “I do not need to be in a state of affairs like this once more.”

-Reuters contributed to this report.

That is an evolving story. . Please verify again for updates


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