TYVASO (treprostinil) - (TETON)

September 2, 2026: United Therapeutics (Nasdaq: UTHR) said the FDA accepted its sNDA for nebulized Tyvaso (treprostinil) Inhalation Solution for idiopathic pulmonary fibrosis (IPF), with review expected to be complete in late April 2027. Tyvaso is not approved for IPF and remains investigational for IPF and progressive pulmonary fibrosis (PPF).

The filing is based on Phase 3 TETON-1 and TETON-2. In a combined analysis, nebulized Tyvaso met the primary endpoint, showing statistically significant superiority to placebo in change in absolute forced vital capacity (FVC) from baseline to week 52, with a 111.8 mL benefit (Hodges-Lehmann estimate; 95% CI 79.7 to 144.0 mL; p<0.0001) in a broadly background-treated IPF population. The combined analysis also showed statistical significance for most key secondary endpoints, including reduced risk of clinical worsening, reduced risk of acute IPF exacerbation, and changes in percent predicted FVC, K-BILD quality-of-life score, and DLCO.

TETON-1 data were presented at the 2026 American Thoracic Society meeting; TETON-2 and combined TETON results were published in The New England Journal of Medicine. TETON-OLE is ongoing, and TETON-PPF has completed enrollment.