FDA accepts NDA submission to add to Liquidia’s Yutrepia label

Liquidia Corporation announced that the FDA accepted for review the company’s amendment to the tentatively approved new drug application, NDA, for Yutrepia 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. 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.