ALXN - Alexion to pause further enrolment in global late-stage COVID-19 study of ULTOMIRIS

Alexion Pharmaceuticals (ALXN) announces the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation.This decision is based on the recommendation of an independent data monitoring committee ((IDMC)), following their review of data from a pre-specified interim analysis.The study will continue for patients already enrolled, including completion of all study visits and planned ULTOMIRIS dosing according to the study protocol. There were no new safety findings observed.The IDMC’s recommendation was based on a pre-planned interim analysis of the primary endpoint – survival at Day 29 – once 122 patients completed the 29-day primary evaluation period.

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Alexion to pause further enrolment in global late-stage COVID-19 study of ULTOMIRIS