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Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

 
• By Michael McCaughan

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

a long time ago on vintage typewriter (shutterstock)
• Source: Shutterstock

The US Food & Drug Advisory Committee review of Biogen, Inc.’s proposed Alzheimer’s therapy aducanumab was an astonishing and unusual event, both because FDA came to the committee in a role that felt almost like a co-sponsor of the application, and because the committee so utterly rejected FDA’s clearly positive read on the admittedly complex efficacy data for the application. (Also see "Aducanumab Fall-Out: An Inexpedient Use Of ‘Expedited’ Review" - Pink Sheet, 12 November, 2020.)

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