David Knopman, MD, a clinical neurologist from Rochester, Minn.-based Mayo Clinic, has resigned after the FDA recently approved Biogen's Alzheimer's drug aducanumab over advisory committee members' objections, according to The Washington Post.
Dr. Knopman, who was a member of the FDA's expert panel for nervous system therapies, told the newspaper June 9 that he did not "wish to be part of a sham process" that led to the FDA's approval of aducanumab, branded under the name Aduhelm.
He also told FDA officials in an email shared with the Post: "The whole saga of the approval of aducanumab … made a mockery of the [advisory] committee's consultative process. While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained."
Joel Perlmutter, MD, of Washington University in St. Louis, resigned as well this week from the FDA Peripheral and Central Nervous System Drugs Advisory Committee over the drug approval, which was done using an accelerated approval pathway. He told STAT in an email that he resigned "due to this ruling by the FDA without further discussion with our advisory committee."
The FDA approved 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, with Dr. Knopman recusing himself because he has served as a site investigator for the Alzheimer's treatment, has been skeptical of the drug, citing not enough evidence to show it could slow cognitive decline, according to STAT and the Post.
The FDA declined to comment to The Post about the resignations, saying it does not discuss issues related to individual advisory committee members.
Read the full Post article here and the full STAT article here.