Amylyx’s ALS Drug Brings Questions On Efficacy Data Robustness To US FDA Panel
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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An advisory committee rejection of the proposed ALS therapy AMX0035 amounts to a vote in favor of US FDA’s approach to the review. It also amounts to an implicit rejection of the idea that ALS merits unique approaches given the devastating nature of the illness.