United Therapeutics Corporation announced that its TETON-2 study, evaluating nebulized Tyvaso (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF), met its primary efficacy endpoint. The study demonstrated a statistically significant improvement in absolute forced vital capacity (FVC) relative to placebo.
Specifically, Tyvaso showed superiority over placebo for the change in absolute FVC by 95.6 mL from baseline to week 52 in patients with IPF. Benefits were observed across all subgroups, including those on background therapy, and most secondary endpoints, such as time to first clinical worsening event, also showed statistically significant improvements.
The safety profile of Tyvaso in the TETON-2 study was consistent with previous studies, with no new safety signals identified. United Therapeutics plans to use this data, along with results from the ongoing TETON-1 study, to support a supplemental New Drug Application to the FDA to add IPF to the labeled indications for nebulized Tyvaso, targeting a significant new market opportunity.
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