Liquidia announces FDA approval of Yutrepia

Liquidia (LQDA) announced that the U.S. Food and Drug Administration has approved Yutrepia inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, to improve exercise ability. “Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort,” the company stated. Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: “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.” As previously disclosed, United Therapeutics (UTHR) filed a complaint on May 9, in the U.S. District Court for the Middle District of North Carolina against Liquidia alleging infringement of U.S. Patent No. 11,357,782 and seeks to enjoin Liquidia from commercializing Yutrepia to treat PAH and PH-ILD. United Therapeutics has filed a motion for temporary restraining order and preliminary injunction to block Liquidia from commercially launching Yutrepia. Oral argument on the motion was held on May 20. The motion remains pending with the Court.