A neurologist on an FDA advisory committee has resigned after the federal agency recently approved Biogen's Alzheimer's drug aducanumab over the panel's objection, STAT reported June 8.
Joel Perlmutter, MD, of Washington University in St. Louis, was a member of the FDA's expert panel for nervous system therapies, which recommended against the approval. 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 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.
Approval was done using the FDA's accelerated approval pathway.
"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. "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."
Ten of the 11 members of the expert panel that Dr. Perlmutter was a member of concluded that there was inadequate evidence to show the treatment could slow cognitive decline, according to STAT.
The approval has garnered attention recently in the medical community, including the news that Biogen is working with Cigna and CVS Health on the treatment.
Read the full STAT article here.