United Therapeutics reported positive results from TETON-1, its second Phase III trial testing nebulised Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF). The trial, involving 598 patients over 52 weeks, showed that nebulised Tyvaso was superior to placebo in improving forced vital capacity (FVC) by 130.1 mL, and also achieved statistical significance in reducing the risk of clinical worsening, with numerical improvements in other key endpoints.
The results build on last year’s positive TETON-2 data, and United Therapeutics plans to submit a supplemental NDA to the Food and Drug Administration (FDA) for priority review by the end of summer 2026.
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