United Therapeutics Reports Positive TETON-2 Results for Tyvaso in IPF

United Therapeutics recently announced that its pivotal TETON-2 clinical trial of nebulized Tyvaso (treprostinil) inhalation solution for idiopathic pulmonary fibrosis achieved its primary endpoint. The study revealed a significant improvement in absolute forced vital capacity compared with placebo. Encouraging results were also seen across most secondary endpoints, such as time to first clinical worsening and quality of life measures. Strong outcomes from TETON-2 are intended to support a supplemental New Drug Application to the US Food and Drug Administration for an expanded indication in IPF. The company also intends to consult with the FDA later this year to explore opportunities to accelerate regulatory review. Additionally, more detailed findings are expected to be shared at the upcoming European Respiratory Society Congress in Amsterdam. Tyvaso is already approved for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, and this new data may extend its therapeutic reach to an area with urgent unmet needs.