Liquidia Corporation announced that FDA has accepted a resubmission of its NDA for Yutrepia dry powder treprostinil for inhalation for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) with a PDUFA goal date of May 24, 2025. The FDA tentatively approved Yutrepia for the treatment of PAH in November 2021 and accepted an sNDA to add the PH-ILD indication in September 2023. The agency tentatively approved that sNDA in August 2024.
The new PDUFA goal date will fall one day after the expiration of 3-year new clinical investigation exclusivity for United Therapeutic’s Tyvaso treprostinil DPI, which was approved for the treatment of PAH and PH-ILD in May 2022. United Therapeutics and Liquidia engaged in extensive litigation over the approval of Yutrepia, including United Therapeutics suing the FDA over acceptance of the Yutrepia sNDA and Liquidia suing the agency over the grant of exclusivity to Tyvaso DPI.
Liquidia CEO Roger Jeffs commented, “We are pleased that the FDA has responded promptly to the resubmission that we filed on Monday. We look forward to working with the FDA over the coming months as we seek final approval for Yutrepia and, in the meantime, will continue preparations to support a launch of Yutrepia as soon as possible.”
Read the Liquidia Corporation press release
