Liquidia challenges FDA decision on Yutrepia exclusivity

Liquidia has filed litigation in the U.S. District Court of the District of Columbia that challenges the recent decision by the FDA to grant 3-year new clinical investigation exclusivity to Tyvaso DPI. FDA granted tentative approval of Yutrepia inhalation powder to treat pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PH-ILD, patients on August 16. As a result of the FDA’s award of NCI exclusivity to Tyvaso DPI, the final approval of Yutrepia inhalation powder is currently delayed until after the expiration of the exclusivity on May 23, 2025. 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. Separately, on August 20, United Therapeutics voluntarily dismissed the complaint it had filed against the FDA challenging the FDA’s acceptance of Liquidia’s amended NDA for Yutrepia for review. With the FDA’s grant of tentative approval for Yutrepia , the FDA decided that it was proper for Liquidia to add PH-ILD to the NDA for Yutrepia via an amendment. Liquidia is seeking final approval of Yutrepia as soon as possible.