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District Court Dismisses Dispute Filed by United Therapeutics Against Liquidia
Court will not hear cross-claim that challenges the PH-ILD indication in the tentatively approved NDA for YUTREPIAFDA can grant final approval of YUTREPIA
About this update from Liquidia Corporation
[{"type":"text","content":"Court will not hear cross-claim that challenges the PH-ILD indication in the tentatively approved NDA for YUTREPIAFDA can grant final approval of YUTREPIA after blocking regulatory exclusivity expires on May 23, 2025 MORRISVILLE, N.C., May 02, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that Judge Kelly of the U.S. District Court for the District of Columbia (District Court) dismissed, without prejudice, the cross-claim filed by United Therapeutics (UTHR) that sought to challenge Liquidia’s amendment to its New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the proposed label for YUTREPIA. In its ruling, the District Court determined that UTHR’s claim was unripe and that UTHR had failed to plausibly allege that it has standing. Dr. Roger Jeffs, CEO, Liquidia said: “We are pleased with the court’s decision to dismiss this cross-claim, specifically holding that UTHR failed to establish standing. We also continue to believe that the FDA was correct to accept, and subsequently tentatively approve, our amended NDA for YUTREPIA to include the PH-ILD indication. We remain laser focused on the potential final approval of YUTREPIA following the expiration of gating regulatory exclusivity on May 23, 2025, and look forward to delivering what we believe will become the prostacyclin of first choice for patients with PAH and PH-ILD and the physicians who treat them.” UTHR has the right to appeal the Court’s ruling. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA of May 24, 2025. About Liquidia CorporationLiquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial...