United Therapeutics’ Tyvaso Succeeds in Phase 3 IPF Trial, Marking Major Advance in Lung Disease Treatment

United Therapeutics' nebulized Tyvaso (treprostinil) achieved positive results in the Phase 3 TETON-2 trial for idiopathic pulmonary fibrosis (IPF), meeting its primary efficacy endpoint of improving absolute forced vital capacity (FVC) compared to placebo over 52 weeks1234.

The improvement in absolute FVC was 95.6 mL greater with Tyvaso than placebo (p < 0.0001)14.

Positive effects were consistent across all subgroups, including different background therapies (nintedanib, pirfenidone), smoking status, and use of supplemental oxygen4.

Statistically significant improvements were also observed in several key secondary endpoints, such as time to first clinical worsening event, percent predicted FVC, and quality of life measures4.

The successful trial results triggered a surge of over 33% in United Therapeutics' share price, reflecting market optimism for the drug's future in an estimated $4 billion-plus new market if approved for IPF125.

These results set the stage for United Therapeutics to file an sNDA with the U.S. FDA for IPF, potentially expanding Tyvaso's approved use beyond current indications1.

Sources:

1. https://www.bioworld.com/articles/723786-uniteds-tyvaso-surprise-in-ipf-potentially-opens-4b-market

2. https://www.alphaspread.com/market-news/stock-movements/united-therapeutics-tyvaso-succeeds-in-key-study-for-lung-disease-shares-surge

3. https://firstwordpharma.com/story/5993986

4. https://www.biospace.com/press-releases/united-therapeutics-corporation-announces-teton-2-pivotal-study-of-tyvaso-meets-primary-endpoint-for-the-treatment-of-idiopathic-pulmonary-fibrosis

5. https://www.fiercepharma.com/pharma/united-therapeutics-plots-tyvaso-lung-disease-expansion-overwhelmingly-positive-trial-win