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.

Drug Review Profile: Relyvrio
Amylyx attempted to rely on historical controls in showing a survival benefit with Relyvrio in a Phase II trial. • Source: Shutterstock

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