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Thursday, January 31, 2019

United Therapeutics data in Orenitram study met primary endpoints

United Therapeutics announced that key data from the FREEDOM-EV study of Orenitram extended-release tablets were shared during an oral presentation at the Pulmonary Vascular Research Institute Annual World Congress on Pulmonary Vascular Disease in Barcelona, Spain. The presentation was given by R. James White, M.D., Ph.D., Professor of Medicine, Pharmacology & Physiology in the Division of Pulmonary & Critical Care Medicine at the University of Rochester Medical Center and steering committee member for the FREEDOM-EV study. The primary endpoint of this pivotal, double-blind, placebo-controlled, event-driven trial in patients with pulmonary arterial hypertension was met. Orenitram decreased the risk of adjudicated clinical worsening events by 26% compared to placebo. These results were largely driven by delay in disease progression; Orenitram decreased the risk of disease progression by 61% compared with placebo. Mortality was similar between Orenitram and placebo groups at the end of randomized treatment. However, in participants for which data are available, Orenitram was associated with a 37% decreased risk of mortality compared with placebo. United Therapeutics has submitted the FREEDOM-EV study results to the U.S. Food and Drug Administration in support of a potential label amendment for Orenitram and is evaluating whether the results could support marketing applications outside the United States.

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