Press release
United Therapeutics Announces The Lancet Respiratory Medicine Publication Of Post-Hoc Analysis Of FVC Change From The Tyvaso® INCREASE Study
Forced vital capacity improvement observed during the INCREASE study in patients with idiopathic pulmonary fibrosis represents the basis of the TETON
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[{"type":"text","content":"Forced vital capacity improvement observed during the INCREASE study in patients with idiopathic pulmonary fibrosis represents the basis of the TETON registration study of Tyvaso in IPF\n\n\nSILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 30, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced the publication in The Lancet Respiratory Medicine of a post-hoc analysis of forced vital capacity (FVC) change in patients during the INCREASE study of Tyvaso® (treprostinil) Inhalation Solution in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3 pulmonary hypertension).\nThe analysis demonstrated that inhaled treprostinil was associated with improvements in FVC compared to placebo over 16 weeks. The improvement was most evident in patients with idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, and life-threatening lung disease of unknown cause with a median survival of 2-3 years.1,2 This analysis, together with literature demonstrating the in vitro antifibrotic effects of treprostinil, represent the basis of the pivotal TETON study of Tyvaso in patients with IPF.3,4\n\"I am encouraged by the improvement in FVC observed in subgroups such as IPF in this post-hoc analysis of the INCREASE study data,\" said Steven Nathan, M.D., an INCREASE study investigator and Steering Committee member, Director of the Advanced Lung Disease Program and Director of the Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Va., and Professor of Medicine at Virginia Commonwealth University-Inova Campus. \"These data, collected in patients presenting with IPF plus pulmonary hypertension, warrant the further investigation of inhaled treprostinil's effects in patients diagnosed with IPF alone, before their disease progresses and they develop pulmonary hypertension.\"\n\"Patients with IPF have generally used two therapies that modestly slow the progression of their disease but come with challenging side effects that can make treatment difficult,\" said Gil Golden, M.D., Ph.D., Chief Medical Officer at United Therapeutics. \"This analysis is exciting because rather than slowing down the rate of FVC deterioration, Tyvaso actually improved FVC in the relatively short 16-week duration of the INCREASE study. If the TETON study supports eventual app...