United Therapeutics reported full Phase 3 TETON-2 trial results for nebulized Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) that were published in The New England Journal of Medicine. The study met its primary endpoint, with median forced vital capacity $(FVC)$ change at week 52 of -49.9 mL with Tyvaso versus -136.4 mL with placebo. Tyvaso reduced the risk of a clinical worsening event by 29% versus placebo (hazard ratio 0.71). The randomized, double-blind trial enrolled 597 patients (298 Tyvaso; 295 placebo), and 75% were on background antifibrotic therapy. United Therapeutics said it plans to submit a supplemental New Drug Application to the FDA in the second half of 2026 following results from the ongoing TETON-1 study, which it said are expected soon.
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