Treprostinil Approved to Delay Disease Progression in PAH - Pulmonology Advisor
Treprostinil Approved to Delay Disease Progression in PAH - Pulmonology Advisor Treprostinil Approved to Delay Disease Progression in PAH - Pulmonology Advisor Posted: 23 Oct 2019 07:30 AM PDT 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...