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A third member of a panel of external advisors to the US Food and Drug Administration resigned in protest of the agency’s decision to approve an Alzheimer’s treatment offered by Biogen Inc (BIIB.O) despite the panel’s recommendation not to.
Aaron Kesselheim, a professor of medicine at Harvard Medical School who has served on the Food and Drug Administration’s Nervous System Drugs Advisory Committee since 2015, told Reuters Thursday that he is stepping down from the panel.
“The rationale was that the FDA needed to re-evaluate how it requested and used advisory committees…because I didn’t think the firm recommendations from the committee in this case…were adequately integrated into the decision-making process,” Kesselheim said in an email. mail.
He cited the Food and Drug Administration’s decision to approve Sarepta Therapeutic Inc (SRPT.O), eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of a regulator that approved a drug against recommendations of its advisory committee.
Stat News first reported his departure.
On Tuesday, a member of the advisory group that voted against approval, University of Washington neurologist Dr. Joel Perlmutter, resigned from the panel, citing the Food and Drug Administration’s approval of Addhelm.
Mayo Clinic neurologist Dr. David Knopman said he was resigning on Wednesday.
The 11-member panel voted almost unanimously in November that Biogen should not be approved, citing inconclusive evidence that the drug was effective.
The US Food and Drug Administration (FDA) on Monday gave “rapid approval” to the drug, based on evidence that it can reduce potential contributing factors to Alzheimer’s disease, rather than demonstrating a clear benefit against the disease.
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