At the end of March 2025, the FDA accepted Liquidia Corporations’s resubmitted NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to Liquidia, the agency has now approved Yutrepia for both indications.
The FDA tentatively approved Yutrepia in November 2021 for the treatment of pulmonary arterial hypertension (PAH) and tentatively approved an sNDA to add the PH-ILH indication in 2024. Liquidia notes that United Therapeutics, which previously sued both Liquidia and the FDA to stop approval of Yutrepia, has recently filed another suit and has asked a court to block Liquidia from launching the DPI now that it has been approved.
Liquidia CEO Roger Jeffs commented, “Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability. Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality. With today’s milestone, our commercial team is prepared to launch Yutrepia and bring meaningful change to the lives of patients in need, and we look forward to speaking with physicians and patients about the unique benefits of Yutrepia in the days and weeks ahead.”
Read the Liquidia Corporation press release
