United Therapeutics Corporation Announces Full Results of TETON-2 Phase 3 Clinical Trial Published in The New England Journal of Medicine

The pivotal study of Tyvaso® (treprostinil) Inhalation Solution demonstrated a statistically significant preservation of lung function across all subgroups, as measured by absolute forced vital capacity (FVC), and fewer clinical worsening events, compared with placebo over 52 weeks in patients with idiopathic pulmonary fibrosis (IPF)

Study authors noted TETON-2 is the first study to show that an inhaled therapy slowed progression of fibrosis as assessed by FVC change in patients with IPF

The trial population reflected the characteristics of a general population of IPF patients, with 75% on background antifibrotic therapy, demonstrating nebulized Tyvaso’s differentiated anti-fibrotic properties

If approved, nebulized Tyvaso will be the first and only inhaled anti-fibrotic treatment for IPF

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the New England Journal of Medicine has published full results of its phase 3 TETON-2 study evaluating the use of nebulized Tyvaso for the treatment of IPF. The publication is available online at NEJM.org.

The study met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was −49.9 mL (95% confidence interval [CI], −79.2 to −19.5) in the nebulized Tyvaso group and −136.4 mL (95% CI, −172.5 to −104.0) in the placebo group, and the between group difference was 95.6 mL (95% CI, 52.2 to 139.0; P