According to United Therapeutics, the U.S. Food and Drug Administration has accepted a supplemental new drug application for nebulized Tyvaso (treprostinil) inhalation solution to treat idiopathic pulmonary fibrosis, and the company anticipates the agency’s review to be complete in late April 2027.
The company claims that, if approved, nebulized Tyvaso would be the first and only inhaled anti-fibrotic treatment for IPF.
The filing was based on pooled positive results from the phase 3 TETON-1 and TETON-2 studies; combined analyses met the primary efficacy endpoint with an absolute forced vital capacity improvement of 111.8 mL (Hodges-Lehmann estimate, 95% confidence interval 79.7 to 144.0 mL; p<0.0001) from baseline to week 52 in an IPF population broadly treated with background therapy.
The combined analyses also achieved statistical significance for most key secondary endpoints, including reduced risk of clinical worsening and reduced risk of acute IPF exacerbation and percent improvements in predicted FVC, K-BILD quality of life measures, and DLCO.
Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF, and nebulized Tyvaso remains investigational for IPF and progressive pulmonary fibrosis.
