The FDA has accepted a supplemental NDA for United Therapeutics’s Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), the company said. In February 2020, United Therapeutics announced that the Phase 3 INCREASE study of Tyvaso in PH-ILD patients had met its primary endpoint.
Tyvaso was approved by the FDA for the treatment of pulmonary arterial hypertension (PAH) in 2009. The most recent sNDA approved until now was when the agency okayed use of an updated nebulizer for delivery of the inhalation solution in 2017. A decision on the current sNDA is expected by April 2021.
United Therapeutics Chairman and CEO Martine Rothblatt commented, “Tyvaso, if approved by the FDA, would be the first and only therapeutic approved for the treatment of PH-ILD, a condition that afflicts approximately 30,000 people in the United States. We look forward to working with the agency during the regulatory review process, with the goal of expanding the population of patients with pulmonary hypertension who could benefit from this important medicine.”
Read the United Therapeutics press release.
