United Therapeutics Corporation (NASDAQ: UTHR) announced that its TETON-1 study of nebulized Tyvaso for idiopathic pulmonary fibrosis met its primary efficacy endpoint, demonstrating superiority over placebo for change in absolute forced vital capacity by 130.1 mL from baseline to week 52.

The 598-patient, phase 3 study showed nebulized Tyvaso achieved statistical significance for reducing the risk of clinical worsening and demonstrated numerical improvement in secondary endpoints including time to first acute exacerbation and changes in quality of life measures. The treatment was well-tolerated with a safety profile consistent with previous studies.

Integrated analyses of TETON-1 and the previously reported TETON-2 study showed statistically significant treatment effects compared to placebo for the primary endpoint of change in absolute forced vital capacity by 111.8 mL and most secondary endpoints. Benefits were observed across patient subgroups regardless of background therapy use, smoking status, or supplemental oxygen use.

The company plans to submit a supplemental New Drug Application to the FDA by summer's end seeking priority review to add idiopathic pulmonary fibrosis to Tyvaso's labeled indications. Both the FDA and European Medicines Agency have granted orphan designation for treprostinil to treat the condition.

Idiopathic pulmonary fibrosis is a progressive scarring disease of the lungs that affects an estimated 100,000 patients in the United States. Tyvaso is currently approved for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The information is based on a company press release statement.