Third member of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee has resigned in protest over the agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease. Two members, David S. Knopman, a neurologist at the Mayo Clinic, and Joel S. Perlmutter, a neurologist at Washington University in St. Louis, resigned in protest earlier.
Now, Aaron Kesselheim, a professor of Medicine at Harvard Medical School, has stepped down. Kesselheim served on the advisory committee since 2015.
“My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees … because I didn’t think that the firm recommendations from the committee in this case … were appropriately integrated into the decision-making process,” Kesselheim told Reuters.
In November 2020, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee met to discuss and vote on a recommendation for the drug, which is an antibody against beta-amyloid, a key factor in Alzheimer’s disease. To the question, “Does Study 302 (EMERGE), viewed independently and without regard for Study 301 (ENGAGE), provide strong evidence that supports the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”
The committee voted 1 yes, 8 no, and 2 uncertain. Another question was, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” The committee voted 0 yes, 7 no and 4 uncertain.
Another question was, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?” The committee voted 5 yes, 0 no and 6 uncertain. And finally, to the question, “in light of the understanding provided by the exploratory analyses of Study 301 and Study 302, along with the results of Study 103 and evidence of a pharmacodynamic effect on Alzheimer’s disease pathophysiology, is it reasonable to consider Study 302 as primary evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” The committee voted 0 yes, 10 no and 1 uncertain.