Biogen's Aducanumab Advisory Committee Will Test US FDA's 'Substantial Evidence' Flexibility

 
• By Sue Sutter

Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.

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An FDA panel will consider whether aducanumab should be the first disease-modifying treatment approved for Alzheimer’s • Source: Shutterstock

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