United Therapeutics says Tyvaso meets primary endpoint in TETON-1 IPF trial

• United Therapeutics disclosed full Phase 3 TETON-1 results for nebulized Tyvaso in idiopathic pulmonary fibrosis, published in The New England Journal of Medicine, with results already presented at the American Thoracic Society meeting.
• The trial met its main goal by showing better preservation of lung function versus placebo, with a lower risk of clinical worsening.
• Pooled analyses from TETON-1 and the companion TETON-2 study also showed statistically significant benefits across the primary endpoint and most key secondary measures, with survival trending favorably but not reaching statistical significance.
• The company plans to seek priority review for a supplemental New Drug Application to add IPF to Tyvaso’s label, targeting submission to the FDA by the end of summer.
• Tyvaso remains investigational for IPF in the US, positioning the filing as a potential expansion beyond its current approved uses.

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