FDA accepts filing sNDA for Tyvaso inhaled solution for the treatment of pulmonary hypertension associated with interstitial lung disease .- United Therapeutics

United Therapeutics Corporation announced that the FDA accepted for review the supplemental New Drug Application (sNDA) for Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in April 2021. The sNDA is based on data from the phase III INCREASE clinical study of Tyvaso in adult patients suffering from World Health Organization (WHO) Group 3 PH-ILD. As previously announced on February 24, 2020, the INCREASE study met its primary endpoint as Tyvaso increased six-minute walk distance (6MWD) by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. In addition, the treatment difference in 6MWD at Week 16 was statistically significant when analyzed using Mixed Model Repeated Measurement (31 meters; P<0.001). benefits of tyvaso were observed across several key subgroups, including etiology of ph-ild, disease severity, age, gender, dose, and baseline hemodynamics. significant improvements were also observed in each of the study's secondary endpoints, including reduction in the cardiac biomarker nt-probnp, time to first clinical worsening event, change in peak 6mwd at week 12, and change in trough 6mwd at week 15. treatment with tyvaso of up to 12 breaths per session, four times daily, in the increase study was well tolerated. the safety profile was consistent with previous tyvaso studies in pulmonary arterial hypertension and known prostacyclin-related adverse events>