Two FDA Committee Members Resign Over Approval Biogen’s New Alzheimer’s Drug
Two members of an advisory committee of US Food and Drug Administration have resigned over the regulator’s decision to approve Biogen Inc.’s (BIIB) new Alzheimer’s drug.
Mayo Clinic neurologist Dr. David Knopman, a panel member who recused from the advisors’ meeting to review the drug due to conflict of interest, resigned on Wednesday.
“I resigned from the PCNS committee because if I ever were asked to serve on a future panel, I wouldn’t have wanted to be treated in the disrespectful way that the aducanumab external advisers were treated,” he said to CNN.
“While I disagree with the decision to approve aducanumab, we in the clinical care and clinical research worlds will simply have to learn to adapt to the new circumstances.”
According to health-care magazine STAT News, a second member of the committee, Dr. Joel Perlmutter, has also resigned.
The FDA on Monday approved Aduhelm, developed by Biogen/Eisai, the drug is the treatment for Alzheimer’s to be approved in 18 years.
The development of the Alzheimer’s drugs has been plagued by a high failure rate. In March 2019, Biogen and Eisai discontinued their global late-stage trials based on results of a futility analysis, which indicated the trials were unlikely to meet their primary endpoint upon completion.
The FDA approved Aduhelm, despite objections of its advisory Peripheral and Central Nervous System Drugs Advisory Committee.
Last November, the 11-member committee voted nearly in unison that the drug should not to be approved. The panel voted 0 yes, 10 no and 1 uncertain that it is “reasonable” to consider the single phase III positive study, as primary evidence of effectiveness of Aducanumab for the treatment of Alzheimer’s disease.
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