United Therapeutics announced positive results from the TETON-1 clinical study of Tyvaso for idiopathic pulmonary fibrosis, meeting its primary endpoint and demonstrating superiority over placebo.
Key takeaways
The TETON-1 study met its primary efficacy endpoint, showing superiority over placebo for change in absolute forced vital capacity by 130.1 mL (p<0.0001).
Nebulized Tyvaso reduced the risk of clinical worsening and showed numerical improvement in secondary endpoints including time to first acute exacerbation of IPF.
United Therapeutics plans to seek priority review of a supplemental New Drug Application to the FDA by the end of summer 2026 to add IPF to Tyvaso's labeled indications.
Integrated analyses of TETON-1 and TETON-2 showed statistically significant treatment effects for the primary endpoint of change in absolute FVC by 111.8 mL (p<0.0001).
The safety profile of nebulized Tyvaso was consistent with previous studies and known prostacyclin-related adverse events, with no new safety signals observed.