In a June 16 letter to HHS Secretary Xavier Becerra, Public Citizen stated that the FDA approved the drug “despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury.”
The decision “to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Public Citizen said in its letter.
The FDA approved aducanumab, branded under the name Aduhelm, June 7 using its accelerated approval pathway. The approval marked 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.
In a news release the day of the approval, Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said: “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. 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.”
The FDA should have rejected the drug and required another large, placebo-controlled clinical trial before further considering approval, Public Citizen said. It called on HHS to immediately request the resignations or otherwise seek the removal of acting FDA Commissioner Janet Woodcock, MD, Dr. Cavazzoni, andBilly Dunn, MD, director of the Center for Drug Evaluation and Research’s office of neuroscience.
Aaron Kesselheim, MD, a professor of medicine at Harvard Medical School in Boston, David Knopman, MD, a clinical neurologist from Rochester, Minn.-based Mayo Clinic, and Joel Perlmutter, MD, of Washington University in St. Louis, have all resigned from the FDA Peripheral and Central Nervous System Advisory Committee over the approval decision.
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