Phase III FREEDOM-EV study shows Orenitram delays disease progression in pulmonary arterial hypertension patients- United Therapeutics

United Therapeutics Corporation announced that preliminary analysis indicates that the FREEDOM-EV clinical study of Orenitram (treprostinil) extended-release tablets in patients suffering from pulmonary arterial hypertension (PAH) has met its primary endpoint of delayed time to first clinical worsening event. Orenitram, when taken with an oral PAH background therapy, decreased the risk of a morbidity/mortality event versus placebo by 26% (p=0.0391).

Efficacy was observed across the following key subgroups: age, gender, World Health Organization (WHO) functnal ioclass, PAH etiology and background PAH therapy. Secondary endpoints included change from baseline in six-minute walk distance (6MWD), N?terminal pro-brain natriuretic peptide levels, combined 6MWD and Borg dyspnea score (shortness of breath test) at week 24. Analysis of these secondary endpoints is ongoing. Orenitram is already indicated to improve exercise capacity and has been an important part of the PAH treatment armamentarium since 2014.

United Therapeutics plans to submit the results to the FDA in support of a label amendment to reflect the FREEDOM-EV results, and is evaluating whether the results could support marketing applications for Orenitram outside the United States.

> Comment: Orenitram is already indicated to improve exercise capacity and has been an important part of PAH treatment since 2014. FREEDOM-EV expands on these benefits by demonstrating that Orenitram also delays disease progression.