Phase III FREEDOM-EV study of Orenitram meets primary endpoint in pulmonary arterial hypertension.- United Therapeutics

United Therapeutics announced that key data from the phase III FREEDOM-EV study of Orenitram (treprostinil) extended-release tablets shows that the primary endpoint of this pivotal, double-blind, placebo-controlled, event-driven trial in patients with pulmonary arterial hypertension (PAH) was met.

Orenitram decreased the risk of adjudicated clinical worsening events by 26% compared to placebo (p=0.0391). These results were largely driven by delay in disease progression; Orenitram decreased the risk of disease progression by 61% compared with placebo (p=0.0002). Mortality was similar between Orenitram and placebo groups at the end of randomized treatment. However, in participants for which data are available (89%), Orenitram was associated with a 37% decreased risk of mortality compared with placebo (p=0.0324) at study closure (which includes additional data accrued in the open-label extension study).

United Therapeutics has submitted the FREEDOM-EV study results to the FDA in support of a potential label amendment for Orenitram and is evaluating whether the results could support marketing applications outside the United States. Data were shared at the Pulmonary Vascular Research Institute Annual World Congress on Pulmonary Vascular Disease.