A 3rd member of a panel of outdoor advisers to the U.S. Meals and Drug Administration has resigned in protest over the company’s resolution to approve Biogen Inc’s Alzheimer’s illness remedy regardless of the committee’s advice in opposition to doing so.
Aaron Kesselheim, a Professor of Medication at Harvard Medical College who had served on the FDA’s advisory committee for nervous system medicine since 2015, instructed Reuters on Thursday he was stepping down from the panel.
“My rationale was that the FDA must re-evaluate the way it solicits and makes use of the advisory committees … as a result of I didn’t assume that the agency suggestions from the committee on this case … have been appropriately built-in into the decision-making course of,” Kesselheim stated in an e mail.
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He cited FDA’s resolution to approve Sarepta Therapeutic Inc’s drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as one other instance of the regulator approving a drug in opposition to the suggestions of its advisory committee.
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Stat Information first reported his departure.
On Tuesday, a member of the advisory group who voted in opposition to the approval, Washington College neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA’s approval of Aduhelm.
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Mayo Clinic neurologist Dr. David Knopman stated he resigned on Wednesday.
The 11-member committee voted almost unanimously in November that Biogen’s drug shouldn’t be permitted, citing inconclusive proof that the drug was efficient.
The FDA on Monday gave the drug “accelerated approval,” primarily based on proof that it could actually scale back a possible contributor to Alzheimer’s, quite than proof of a transparent profit in opposition to the illness.
(Reporting by Julie Steenhuysen and Carl O’Donnell; enhancing by Grant McCool)