The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Orenitram (treprostinil; United Therapeutics) extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression, in addition to improving exercise capacity.
The approval was based on data from the phase 3, multicenter, double-blind, placebo-controlled, FREEDOM-EV study that evaluated the effect of Orenitram on the progression of PAH in 690 patients receiving background PAH monotherapy (PDE-5 inhibitor, endothelin receptor antagonist or soluble guanylate cyclase stimulator). Patients were randomized 1:1 to receive 3 daily doses of Orenitram or placebo. The primary end point was the time to first clinical worsening event.
Findings from the study showed treatment with Orenitram resulted in a 25% decrease in the risk of adjudicated clinical worsening events, compared with placebo (hazard ratio [HR] 0.75; 95% CI; 0.57, 0.99; P =.039). This effect was attributed to a delay in disease progression (defined as a 15% decline in 6MWD plus an increase in either WHO Functional Class or worsening of signs or symptoms of right heart failure) in Orenitram-treated patients (HR 0.39; 95% CI; 0.23, 0.66; P =.0002). Subgroup analyses showed that the treatment effect on time to first clinical worsening event due to disease progression was found to be consistent for various subgroups.
Orenitram, an oral prostacyclin mimetic, is available as 0.125mg, 0.25mg, 1mg, 2.5mg, and 5mg extended-release tablets in 10- and 100-count bottles.
For more information visit orenitram.com.