Research Triangle Park, N.C.–based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020.
The posthoc analysis of FVC change in patients during the Increase study of Tyvaso was published in The Lancet Respiratory Medicine. The analysis demonstrated that inhaled treprostinil was associated with improvements in FVC compared to placebo over 16 weeks, with improvements most evident in patients with idiopathic pulmonary fibrosis (IPF), according to a news release.
United Therapeutics said the analysis, combined with literature demonstrating the in vitro antifibrotic effects of treprostinil, offer the basis for the pivotal Teton study of Tyvaso in patients with IPF.
Positive data from the posthoc analysis adds to the reported data from the Increase trial that led to FDA approval, which met its primary endpoint (demonstration of a significant improvement in six-minute walk distance) and observed improvements in each of the secondary endpoints, including a reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak six-minute walk distance at week 12 and change in trough six-minute walk distance at week 15.
“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,” United Therapeutics CMO Gil Golden said in the release. “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.”
