Amylyx’s ALS Drug Brings Questions On Efficacy Data Robustness To US FDA Panel

 
• By Sue Sutter

Citing numerous concerns about design of the Phase II CENTAUR trial and statistical robustness of the results, agency reviewers question whether a single study provides substantial evidence of efficacy for approval of AMX0035.

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Amylyx relied on a 'questionable linearity assumption' in its primary endpoint analysis for the CENTAUR study, FDA said. • Source: Alamy

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