Liquidia Corp(US:LQDA) GlobeNewswire News Room·2024-08-22 10:00Core Viewpoint - Liquidia Corporation has filed litigation against the FDA's decision to grant 3-year new clinical investigation exclusivity to Tyvaso DPI®, which delays the final approval of Liquidia's YUTREPIA™ inhalation powder for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease [1][2] Group 1: Company Actions and Legal Proceedings - Liquidia Corporation has initiated litigation in the U.S. District Court of the District of Columbia to challenge the FDA's exclusivity decision, which it believes stifles competition and patient access to alternative treatments [1][2] - The FDA granted tentative approval for YUTREPIA™ on August 16, 2024, but the exclusivity awarded to Tyvaso DPI delays its final approval until May 23, 2025 [1] - United Therapeutics voluntarily dismissed its complaint against the FDA regarding Liquidia's amended NDA for YUTREPIA, allowing the FDA to proceed with the review [3] Group 2: Product Information - YUTREPIA™ is an inhaled dry-powder formulation of treprostinil designed for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [7][9] - The product utilizes Liquidia's PRINT® technology, which allows for precise and uniform drug particle development, enhancing lung deposition [7] - Liquidia is conducting ongoing clinical studies, including the ASCENT trial, to evaluate the safety and tolerability of YUTREPIA in patients with PH-ILD [8] Group 3: Market Context - Pulmonary arterial hypertension (PAH) affects an estimated 45,000 patients in the U.S., with no current cure, making symptom management and quality of life improvement critical [5] - Pulmonary hypertension associated with interstitial lung disease (PH-ILD) has a prevalence of over 60,000 patients in the U.S., with many underlying conditions underdiagnosed [6]