United Therapeutics (NSDQ:UTHR) announced today that it received FDA clearance for its Tyvaso inhalation solution for pulmonary hypertension.
Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release.
With approval, Tyvaso now has two indications, having garnered FDA clearance in July 2009 for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability.
The latest approval of Tyvaso’s supplemental new drug application was supported by data from the Increase trial of adult patients with PH-ILD.
In the multi-center, randomized, double-blind, placebo-controlled, 16-week, parallel-group study of 326 patients, the primary endpoint — demonstration of a significant improvement in six-minute walk distance — was met. Results published in the New England Journal of Medicine also highlighted benefits across subgroups including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics and dose.
The trial also observed improvements in each of the secondary endpoints, including a reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak six-minute walk distance at week 12 and change in trough six-minute walk distance at week 15.
Tyvaso was administered to patients for up to 12 breaths per session, four times daily, through the TD-100 and TD-300 Tyvaso inhalation system and was well-tolerated with the safety profile proving consistent with previous studies.
“The FDA approval of Tyvaso for patients with PH-ILD is a landmark treatment advancement for this vulnerable patient population,” United Therapeutics chairperson & CEO Martine Rothblatt said in the release. “It also underscores our commitment to driving innovation in the field of pulmonary hypertension and expanding the number of patients who can achieve a clinical benefit from Tyvaso. We plan to tap into our experience and expanded infrastructure to bring this safe and effective inhaled therapy to the many patients living with PH-ILD in the United States.”