Two more FDA advisory panel members resign over Biogen aducanumab approval

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• David Knopman and Aaron Kesselheim, members of the FDA advisory committee that last November voted against approval of Biogen's (NASDAQ:BIIB) Aduhelm (aducanumab) for Alzheimer's, have resigned.
• They join Joel Perlmutter, who stepped down earlier this week from the Peripheral and Central Nervous System Drugs Advisory Committee.
• The Washington Post reported that Knopman told the agency in an email that the "saga" behind the approval "made a mockery" of the consultant role of advisory committees.
• In his resignation letter, obtained by Endpoints News, Kesselheim said his decision to leave was prompted by the change to an accelerated approval process, a pathway, he wrote, that was excluded from discussion at the November meeting.
• He called the FDA's decision "probably the worst drug approval decision in recent U.S. history."
• Kesselheim was one of three members of the advisory committee that debated aducanumab who wrote in a March JAMA editorial that the drug should not be approved, mentioning that two pivotal trials found different results.
• Aduhelm was approved on Monday with a label that many believe will allow the drug to be used with many more patients than initially anticipated.
• Biogen shares are up 2.2% to $424 in morning trading.