Phase 3 Trial of Ultomiris in ALS Patients Stopping for Lack of Efficacy

Phase 3 Trial of Ultomiris in ALS Patients Stopping for Lack of Efficacy

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Phase 3 Trial of Ultomiris in ALS Patients Stopping for Lack of Efficacy

Alexion Pharmaceuticals is stopping further work on Ultomiris (ravulizumab) — its approved therapy for complement-associated rare blood disorders — as a potential treatment of amyotrophic lateral sclerosis (ALS) based on interim data from the CHAMPION-ALS Phase 3 clinical trial. While top-line results were expected by mid-2022, the study’s independent data monitoring committee recommended the trial be stopped early due to lack of Ultomiris’ efficacy in a pre-specified interim analysis. No new safety concerns were identified, and the therapy’s safety…

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