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FDA Accepts Submission to Add PH-ILD to YUTREPIA™ Label
Sets PDUFA goal date of January 24, 2024If approved, YUTREPIA would be indicated for treatment of both PAH and PH-ILD MORRISVILLE, N.C., Sept. 25, 2023 (GLOBE
About this update from Liquidia Corporation
[{"type":"text","content":"Sets PDUFA goal date of January 24, 2024If approved, YUTREPIA would be indicated for treatment of both PAH and PH-ILD MORRISVILLE, N.C., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s amendment to the tentatively approved new drug application (NDA) for YUTREPIA™ (treprostinil) inhalation powder in which the Company is seeking to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label. The FDA confirmed the type of resubmission as Class II and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024. Dr. Rajeev Saggar, Chief Medical Officer of Liquidia, said: “We are pleased that the FDA has accepted the submission for review with a PDUFA goal date well in advance of the expiration in March 2024 of the new clinical investigation exclusivity granted to Tyvaso®. If this amendment is approved by FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH). “ The FDA tentatively approved YUTREPIA to treat PAH in November 2021 and confirmed that the addition of the PH-ILD indication will not require any new clinical studies. The launch of YUTREPIA in both indications remains subject to the successful resolution of the ongoing litigation with United Therapeutics and final FDA approval. Additionally, the FDA may not grant final approval of the PH-ILD indication until after the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024. About YUTREPIA™ (treprostinil) inhalation powder YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a convenient, low-resistance, palm-sized device. On November 5, 2021, the FDA issued a tentative approval for YUTREPIA for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. The FDA has confirmed that YUTREPIA may add the indication to treat pulmonary hypertension with interstitial lung disease (PH-ILD) without additional clinical studies. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and ...