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SILVER 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).
The 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
"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."
"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 approval of Tyvaso in patients with IPF, we look forward to providing a new treatment option for these patients with few current treatment options for this life-threatening medical condition."
"We measured FVC in the INCREASE study as a safety endpoint to make sure treatment with Tyvaso was not exacerbating patients' underlying lung diseases. What we found was quite to the contrary, as we saw improvement in lung function among several subgroups including those with PH associated with IPF," said Leigh Peterson, Ph.D., Senior Vice President, Product Development at United Therapeutics. "We are looking to expand on these results in the TETON study, in hopes of demonstrating a label-enabling FVC improvement in patients with IPF. We enrolled the first patients in the TETON study this month."
Tyvaso is approved by the U.S. Food and Drug Administration to treat pulmonary arterial hypertension (PAH; WHO Group 1) and PH-ILD.
About INCREASEThe multicenter, randomized, double-blind, placebo-controlled, 16-week, parallel group INCREASE study evaluated Tyvaso in adult patients suffering from World Health Organization (WHO) Group 3 PH-ILD. A total of 326 patients were enrolled at 93 centers and randomized to inhaled Tyvaso (n=163) four times daily or placebo (n=163). United Therapeuticspreviously announced data from INCREASE showing it met all primary and secondary endpoints.
The primary efficacy endpoint was the change in six-minute walk distance (6MWD) measured at peak exposure from baseline to Week 16. The study showed that treatment with inhaled Tyvaso was well tolerated and improved 6MWD by 21 meters versus placebo (p=0.0043) at week 16 when using a pre-specified worst-case imputation for missing data and Hodges-Lehmann estimate. Tyvaso increased 6MWD by 31 meters relative to placebo after 16 weeks of treatment (p
