Efficacy

Improvements were seen in clinically stable patients already on monotherapy1,2

Median changes in 6mwd with tyvaso at peak exposure

Median 6MWD improvements in Triumph-1 Study of inhaled prostacyclin therapyMedian 6MWD improvements in Triumph-1 Study of inhaled prostacyclin therapy

*6MWD was measured at peak exposure (10-60 minutes after dosing) and trough exposure (≥4 hours after dosing) at week 12 (trough data not shown).

Hodges-Lehmann median difference between TYVASO treatment and placebo groups.

Triumph Study Description1,2

Design: 12-week, multicenter, randomized, double-blind trial of TYVASO or placebo added to an ERA (bosentan) or a PDE-5i (sildenafil) in 235 clinically stable patients (82% female, 18% male) who were NYHA FC III (98%) or IV (2%) at baseline, with 6MWD between 200 m and 450 m.

How administered: TYVASO was initiated at 3 breaths (18 µg) per inhalation section. If clinically tolerated, dosing was increased over the first 2 weeks to reach a target dose of 9 breaths (54 µg) 4 times daily. Average time to target dose – ~3 weeks.

Primary Endpoint: Peak 6MWD at 12 weeks.

Secondary Endpoints: 12-week trough 6MWD, peak 6MWD at Day 1 and 6 weeks, quality of life, Borg Dyspnea Score, NYHA FC, clinical worsening, or signs and symptoms of PAH.



52% of Patients receiving Tyvaso Increased 6MWD By >20 M Compared with 32% receiving placebo2

52% of patients receiving inhaled prostacyclin increased 6 minute walk distance by 20 meters.