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What Did US FDA Do Wrong In Its Review Of Aducanumab? AdCom Members Have A List

 
• By Brenda Sandburg

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

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FDA Advisory Committee has many questions about aducanumab Alzheimer's disease drug • Source: Shutterstock

The US Food and Drug Administration faced a barrage of criticism from members of its advisory committee over its positive review of Biogen, Inc.’s aducanumab Alzheimer’s disease drug. They objected to the way the agency laid out data in a joint briefing document with Biogen, saying FDA weighted the findings in favor of the sponsor and downplayed the discordant results of two Phase III studies.

At its 6 November meeting, the Peripheral and Central Nervous System Drugs Advisory Committee voted that Biogen’s single positive Phase III study could not provide primary evidence of effectiveness for aducanumab for treatment of Alzheimer’s disease

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