According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension since July 2009. United Therapeutics submitted the sNDA for the PH-ILD indication in August 2020, supporting the application with data from the Phase 3 INCREASE study. The company says that it is launching Tyvaso for PH-ILD immediately.
United Therapeutics Chairperson and CEO Martine Rothblatt commented, “The FDA approval of Tyvaso for patients with PH-ILD is a landmark treatment advancement for this vulnerable patient population. 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.”
President and Chief Operating Officer Michael Benkowitz said, “With this approval representing such a breakthrough for PH-ILD patients, we’re treating this indication launch with a sense of urgency. We’ve already expanded our field-based teams by 40% to educate the ILD community on the benefits of Tyvaso and how to properly diagnose PH-ILD. We expect rapid uptake of Tyvaso in this indication and expect to double the number of patients on Tyvaso therapy by the end of 2022, barring any COVID-related delays.”
United Therapeutics is also expected to submit an NDA for a Tyvaso DPI within the next month and has acquired a rare pediatric disease priority review voucher that it intends to use for that application. Earlier this year, the company announced that its BREEZE study had demonstrated the safety of switching PAH patients from Tyvaso inhalation solution to the Tyvaso DPI.
Read the United Therapeutics press release.
