Liquidia Corporation said that the FDA has accepted its sNDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication for Yutrepia treprostinil inhalation powder without requiring any additional studies and has set the PDUFA goal date as January 24, 2024. The FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension In November 2021. Liquidia submitted the sNDA in July 2023.
United Therapeutics’ Tyvaso inhaled treprostinil has new clinical investigation exclusivity through March 2024, so final approval of the sNDA would be delayed until at least that date. United Therapeutics has also been pursuing patent litigation alleging infringement by Yutrepia and filed a new patent infringement suit in September 2023 in response to Liquidia’s submission of the sNDA.
Liquidia Chief Medical Officer Rajeev Saggar commented, “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).”
Read the Liquidia Corporation press release.
