A third member of a panel of external advisors to the US Food and Drug Administration has resigned in protest of the agency’s decision to approve Biogen Inc.’s treatment for Alzheimer’s disease, despite the committee’s recommendation against doing so.
Aaron Kesselheim, a professor of medicine at Harvard Medical School who 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 argument was that the FDA needs to re-evaluate how it solicits and uses advisory committees … because I didn’t think the committee’s firm recommendations in this matter … were appropriately integrated into the process,” Kesselheim said in an email.
He cited the FDA’s decision in 2016 to approve Sarepta Therapeutic Inc.’s drug, etaplirsen, for Duchenne muscular dystrophy, as another example of a regulator approving a drug against its advisory committee’s recommendations.
State News was the first to report his departure.
On Tuesday, a member of the advisory group that voted against the approval, University of Washington neurologist Dr. Joel Perlmutter resigned from the committee, citing the FDA’s approval of EduHelm.
Mayo Clinic neurologist Dr David Knopman said he resigned Wednesday.
An 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 “expedited approval” based on evidence that it may reduce a potential contributor to Alzheimer’s, rather than evidence of clear benefit against the disease.
Credit: www.nbcnews.com /