(RTTNews) - United Therapeutics Corp. (UTHR), Tuesday announced that its TETON-2 study evaluating the use of nebulized Tyvaso (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo.
Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL from baseline to week 52 in patients with IPF. Benefits of Tyvaso were observed across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental oxygen use.
Statistically significant improvements relative to placebo were also observed in most secondary endpoints, including time to first clinical worsening event, as well as changes from baseline to week 52 in percent predicted FVC, King's Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO).
United Therapeutics intends to use the data from both the TETON-2 study and the ongoing TETON-1 study of nebulized Tyvaso (NCT04708782) to support a supplemental New Drug Application to the FDA to add IPF to the labeled indications for nebulized Tyvaso.
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