Update on Favorable Legal and Regulatory Outcomes Clearing Path for Potential FDA approval of YUTREPIA (treprostinil) inhalation powder - Seite 2

In the first action, UTHR filed a lawsuit against FDA in the U.S. District Court for the District of Columbia (Case No. 24-484), and a motion for a temporary restraining order and preliminary injunction, seeking to prevent FDA from approving Liquidia’s amended NDA. After a hearing on March 29, Judge Bates, who is presiding over this lawsuit, denied UTHR’s motion. Specifically, the Court held that the subject of UTHR’s case, FDA’s acceptance of Liquidia’s amended NDA for substantive review, is not a final agency action that UTHR can challenge in court. The Court has scheduled a status conference for April 2 to establish a process for UTHR’s claims to be reevaluated after the FDA acts on the Company’s amended NDA.

In the second action, UTHR filed a lawsuit against the Company in Delaware District Court (Case No. 23-975) alleging that YUTREPIA would infringe U.S. Patent No. 11,826,327 (‘327 patent), which issued in November 2023. UTHR has filed a motion for preliminary injunction to block Liquidia from launching YUTREPIA for PH-ILD. Briefing on UTHR’s motion remains in process.

About YUTREPIA(treprostinil) inhalation powder

YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. The FDA previously issued tentative approval of YUTREPIA for the PAH indication in November 2021. YUTREPIA was designed using Liquidia’s PRINT technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, with the objective of informing YUTREPIA’s dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational studies.