Liquidia provides YUTREPIA regulatory update

Liquidia (LQDA) announced that on March 28, Judge Andrews of the U.S. District Court for the District of Delaware has set aside the injunction that was issued in August 2022 in the lawsuit filed by United Therapeutics (UTHR) in Case No. 1:20-cv-00755-RGA (the Original Hatch-Waxman Litigation). As a result, the U.S. FDA is no longer enjoined from issuing final approval of Liquidia’s New Drug Application for YUTREPIA inhalation powder. Dr. Roger Jeffs, CEO of Liquidia, said: “With the recent decision by Judge Andrews, the path is cleared for us to seek final approval for YUTREPIA. We have submitted the judge’s order to the FDA and look forward to a decision from the FDA in the near future. Our commercial team is fully prepared to launch YUTREPIA in both PAH and PH-ILD should the FDA grant final approval. Once launched, we are confident that YUTREPIA’s convenient, low-effort delivery and wide dosing range will propel the therapy towards our goal of establishing YUTREPIA as the prostacyclin of first choice.” The FDA tentatively approved YUTREPIA to treat pulmonary arterial hypertension in November 2021. In July 2023, the Company amended its NDA to add the indication to treat pulmonary hypertension associated with interstitial lung disease. On March 31, 2024, the new clinical investigation exclusivity granted to Tyvaso to treat PH-ILD expired. The FDA is now able to take final action on YUTREPIA’s amended NDA that seeks approval for both indications. United Therapeutics has filed a notice of appeal with respect to Judge Andrews’ decision to set aside the injunction. In addition, United Therapeutics has filed two separate lawsuits in which it is seeking to obtain new injunctions to prevent launch of YUTREPIA for the treatment of PH-ILD. For both of these actions, UTHR bears the burden of demonstrating, among other things, that it is substantially likely to succeed on the merits and that UTHR will be irreparably harmed if the injunctions are not granted. None of these appeals or actions will impede the company’s launch of YUTREPIA unless UTHR is successful in obtaining the relief it is seeking.