© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, USA on January 26, 2017. REUTERS / Brian Snyder
By Julie Steenhuysen and Carl O’Donnell
(Reuters) – A third member of a panel of external advisers to the US Food and Drug Administration resigned in protest at the agency’s decision to approve the Alzheimer’s disease treatment from Biogen Inc (NASDAQ 🙂 despite the committee’s recommendation not to.
Aaron Kesselheim, a professor of medicine at Harvard Medical School who had been a member of the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday that he was withdrawing from the panel.
“My rationale was that FDA needs to re-evaluate how it solicits and uses advisory committees … because I didn’t think the committee’s firm recommendations in this case … were properly integrated into the decision-making process,” Kesselheim said in a email.
He cited the FDA’s decision to approve Sarepta Therapeutic Inc’s drug eteplirsen for Duchenne muscular dystrophy in 2016 as another example of how the regulator approved a drug against the recommendations of its advisory committee.
Stat News first reported 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 the FDA’s approval of Aduhelm.
Mayo Clinic neurologist Dr. David Knopman said he resigned 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.
FDA in Monday (NASDAQ 🙂 gave the drug an “accelerated approval,” based on evidence that it may reduce a potential contributor to Alzheimer’s, rather than evidence of a clear benefit against the disease.
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