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Amylyx’s ALS Drug Should Wait For Phase III Results, US FDA Panel Says

Executive Summary

Six of 10 advisory committee members say Phase II CENTAUR trial cannot stand on its own to support approval at this time. However, patients and advocates say thousands will die if they have to wait for the Phase III PHOENIX trial to complete in 2024 before the drug becomes widely available.

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Amylyx’s ALS Drug Relyvrio Fails In PHOENIX Confirmatory Study, Setting Up Withdrawal Question

Company will meet with regulators and the broader ALS community to discuss top-line results and make ‘informed decisions,’ which may include voluntary withdrawal. During FDA review, Amylyx had pledged to remove Relyvrio if PHOENIX failed.

Early PHOENIX Data Would Not Have Aided Approval Decision On Amylyx’s Relyvrio – US FDA

Agency considered Amylyx’s plan to submit unblinded efficacy data from the ongoing Phase III trial during the ALS drug's NDA review but ultimately decided against it, citing concerns about study integrity and the small amount of data likely to be available.

Real-World Evidence: Amylyx’s Use Of External Controls To Frame Relyvrio’s Survival Benefit Rife With Problems

The post hoc comparison of an exploratory, long-term survival benefit in the CENTAUR trial to historical controls in two ALS patient databases lacked prespecification and a common treatment protocol, and potential differences in prognostic factors may have confounded the results.

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