What ‘Confirmatory Evidence’ Does US FDA Need When Sponsors Want To Rely On A Single Trial?

 
• By Sue Sutter

Amylyx’s Relyvrio survival data, drawn from a post hoc exploratory survival analysis of randomized patients, and the primary ALS functional endpoint ‘capture distinct concepts,’ FDA states. Use of long-term survival data from the same trial as confirmatory evidence was unusual, but not unique.

Outside the box
Relying on post hoc overall survival data as confirmatory evidence suggests some outside the box thinking by US FDA. • Source: Shutterstock

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