Third FDA Advisory Panel Member Resigns Following Alzheimer’s Drug Approval – –

Third FDA Advisory Panel Member Resigns Following Alzheimer’s Drug Approval – –

A third member of a group of external advisers from the United States Food and Drug Administration resigned to protest the agency’s decision to approve Biogen Inc’s treatment for Alzheimer’s disease despite the committee’s recommendation not to do it.

Aaron Kesselheim, a professor of medicine at Harvard Medical School who has served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.

“My reasoning was that the FDA needs to re-evaluate the way it solicits and uses advisory committees… because I didn’t think the strong recommendations of the committee in this case… were properly incorporated into the decision-making. process, ”Kesselheim said in an email.

He cited the FDA decision to approve Sarepta Therapeutic Inc’s drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.

Stat News first announced his departure.

On Tuesday, an advisory group member who voted against the approval, University of Washington neurologist Dr. Joel Perlmutter, resigned from the committee, citing FDA approval of Aduhelm.

Mayo Clinic neurologist Dr David Knopman announced his resignation on Wednesday.

The 11-member committee voted almost unanimously in November that Biogen’s drug should not be approved, citing inconclusive evidence that the drug was effective.

The FDA on Monday gave the drug “fast track approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s disease, rather than evidence of a clear benefit against the disease.


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