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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

A US Food and Drug Administration advisory committee meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab will offer some insight into the amount of flexibility the agency and its external experts are willing to exercise for neurodegenerative diseases with high unmet need, particularly in the wake of a December 2019 guidance document on the quantum and type of data capable of satisfying the “substantial evidence” standard.

On 6 November, the Peripheral and Central Nervous System Drugs Advisory Committee will consider the benefit/risk profile of aducanumab, an anti-amyloid-beta antibody infusion intended for treatment of Alzheimer’s, according to a notice due to publish in the Federal Register on 29 September. The meeting will be held virtually due to the COVID-19 pandemic

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