Liquidia Files Litigation to Challenge Regulatory Exclusivity Blocking Access to YUTREPIA™ (treprostinil) inhalation powder for Patients Suffering with PAH and PH-ILD

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[{"type":"text","content":"MORRISVILLE, N.C., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that it has filed litigation in the U.S. District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the United States Food and Drug Administration (FDA) to grant 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI®. FDA granted tentative approval of YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) patients on August 16, 2024. As a result of the FDA’s award of NCI exclusivity to Tyvaso DPI, the final approval of YUTREPIA™ (treprostinil) inhalation powder is currently delayed until after the expiration of the exclusivity on May 23, 2025. Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, said: “The FDA’s action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice. This decision violates clear congressional intent to allow NCI exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation. It is our strong belief that the FDA’s decision to grant Tyvaso DPI this new NCI exclusivity should be vacated, and Liquidia should be allowed to bring YUTREPIA to market for the benefit of patients immediately.” In establishing NCI exclusivity, Congress sought to encourage innovation in drug development while also ensuring patient access to alternative drugs through competition. Accordingly, NCI exclusivity is only granted for a period of three years from the date of an FDA approval that is supported by certain types of clinical studies, expressly excluding bioavailability studies and clinical investigations that a drug sponsor has previously submitted to FDA. Additionally, NCI exclusivity is limited in scope to the innovative change supported by the new clinical investigation. Separately, on August 20, 2024, United Therapeutics voluntarily dismissed, without prejudice, the complaint it had filed against the FDA in the U.S. District Court for the District of Columbia, challenging the FDA’s a...

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