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Officials quit in protest over Aduhelm’s approval

Officials quit in protest over Aduhelm’s approval

3 FDA panelists resign over drug approval. FDA approved Biogen’s Aduhelm on June 7th.

Where: United States

The Facts

▪ Three members of the FDA advisory panel, Dr. Joel Perlmutter, Dr. David Knopman, and Professor Aaron Kesselheim, resigned this week to protest the accelerated approval for Biogen’s Alzheimer’s drug Aduhelm.

▪ Dr. Perlmutter stated, “If we approve something where the data is not strong, we have a risk of delaying good therapies and effective therapies for more than a couple of years, for many years. There is a huge danger in approving something that turns out not to be effective.”

▪ Kesselheim tweeted, “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”

▪ On November 6th, 2020, the Peripheral and Central Nervous System Drugs Advisory Committee recommended against Aduhelm’s approval in an 8-1 vote.

▪ Dr. Knopman’s assessment was quoted during the committee meeting, “The evidence that aducanumab has any benefit in persons with Alzheimer’s disease is terribly weak.”

▪ In his resignation letter, Professor Kesselheim wrote, “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.”

▪ On June 7th, The FDA granted accelerated approval to Biogen’s Aduhelm – according to FDA Center for Drug Evaluation and Research director Dr. Patrizia Cavazzoni, “the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

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