Dr. Kesselheim said the decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by the news channel.
According to CNBC, Dr. Kesselheim said it was “clear” to him that the FDA is not “presently capable of adequately integrating the committee’s scientific recommendations into its approval decisions.”
The FDA approved aducanumab, branded under the name Aduhelm, June 7, marking the first FDA-approved Alzheimer’s treatment in two decades. It also was the first treatment approved by the FDA to slow cognitive decline from Alzheimer’s.
“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release the day of the approval. “We examined the clinical trial findings with a fine-tooth comb. We solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee. We listened to the perspectives of the patient community, and we reviewed all relevant data.”
But the advisory committee, which convened in November, has been skeptical of the drug, citing not enough evidence to show it could slow cognitive decline, according to STAT and the The Washington Post.
David Knopman, MD, a clinical neurologist from Rochester, Minn.-based Mayo Clinic, and Joel Perlmutter, MD, of Washington University in St. Louis, also resigned over the treatment’s approval.
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