Press release
United Therapeutics Announces INCREASE Study Of Tyvaso® Meets Primary And All Secondary Endpoints
~ First pivotal clinical trial to demonstrate a benefit in PH-ILD ~ ~ NDA supplement to be filed by mid-year SILVER SPRING, Md. and RESEARCH TRIANGLE PARK,
About this update from United Therapeutics Corporation
[{"type":"text","content":"~ First pivotal clinical trial to demonstrate a benefit in PH-ILD ~\n ~ NDA supplement to be filed by mid-year\n\n\nSILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2020 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) has met its primary efficacy endpoint of demonstrating improvement in six-minute walk distance (6MWD). \n\n \n \n\n \nTyvaso increased six-minute walk distance by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose.\nSignificant improvements were also observed in each of the study's secondary endpoints including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in PAH and known prostacyclin-related adverse events (see the discussion of adverse events below under \"About Tyvaso\").\n\"Patients with both interstitial lung disease and pulmonary hypertension have worse clinical trajectories and earlier death than patients with interstitial lung disease alone. There are currently no approved therapies for these patients and so there is a tremendous unmet need,\" said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women's Hospital and the chair of the INCREASE Study Steering Committee. \"This is the largest clinical trial in this population, and the first to demonstrate a clear benefit. As a clinician, I look forward to soon having an approved treatment to offer these patients with this life-threatening disease.\"\n\"I am pleased to announce the successful outcome of the INCREASE phase III trial of Tyvaso in a unique kind of pulmonary hypertension, a variant that has no approved therapy,\" said Martine Rothbla...