Two members of a panel of external advisers from the United States Food and Drug Administration have resigned in protest against the agency’s decision to approve Biogen Inc’s Aduhelm for the treatment of Alzheimer’s disease despite the recommendation of the committee not to do so.
Mayo Clinic neurologist Dr David Knopman, a panel member who was barred from the November councilors meeting to review the drug because he was a clinical trial researcher of the Biogen drug, said he had resigned Wednesday.
“I was very disappointed with the way the advisory committee’s contribution was handled by the FDA,” Dr Knopman told Reuters. “I don’t want to be put in a position like this anymore.”
The 11-member committee voted almost unanimously in November that Biogen’s drug should not be approved, citing inconclusive evidence that the drug was effective. Due to his challenge, Knopman did not participate in the vote.
The FDA on Monday gave the drug “fast track approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s disease, rather than evidence of a clear benefit against the disease.
On Tuesday, an advisory group member who voted against approval, University of Washington neurologist Dr. Joel Perlmutter, resigned from the committee, citing FDA approval of Aduhelm without further discussion with his advisers. .
The FDA said it does not comment on issues related to individual members of advisory committees.