Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval By Reuters

2/2 © Reuters. FILE PHOTO: An indication marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder 2/2 By Julie Steenhuysen and Carl O’Donnell (Reuters) – A 3rd member of a panel of out of doors advisers to the U.S. Meals and Drug Administration has resigned in protest over the company’s choice


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© Reuters. FILE PHOTO: An indication marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder

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By Julie Steenhuysen and Carl O’Donnell

(Reuters) – A 3rd member of a panel of out of doors advisers to the U.S. Meals and Drug Administration has resigned in protest over the company’s choice to approve Biogen Inc (NASDAQ:)’s Alzheimer’s illness therapy regardless of the committee’s suggestion in opposition to doing so.

Aaron Kesselheim, a Professor of Medication at Harvard Medical Faculty 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 mentioned in an e mail.

He cited FDA’s choice 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.

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.

Mayo Clinic neurologist Dr. David Knopman mentioned he resigned on Wednesday.

The 11-member committee voted almost unanimously in November that Biogen’s drug shouldn’t be accepted, citing inconclusive proof that the drug was efficient.

The FDA on Monday (NASDAQ:) gave the drug “accelerated approval,” based mostly on proof that it could possibly scale back a possible contributor to Alzheimer’s, reasonably than proof of a transparent profit in opposition to the illness.

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