According to Liquidia Corporation, the FDA has granted tentative approval of the company’s sNDA for Yutrepia dry powder treprostinil for inhalation powder to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. In November 2021, the FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension (PAH) and in September 2023, the agency accepted the sNDA to add the PH-ILD indication.
Liquidia notes that the United Therapeutics’ Tyvaso treprostinil DPI, which was approved for the treatment of both PAH and PH-ILD in May 2022, currently has regulatory exclusivity until May 23, 2025. As a result, final approval of the NDA may take place after that date. The company says that it “remains committed to addressing the unmet needs of PAH and PH-ILD patients” and intends to “seek final approval . . . as early as possible.”
Earlier this year, United Therapeutics sued the FDA over the agency’s handling of the Yutrepia sNDA, calling the supplemental application “unlawful.” In May 2024, a judge denied United Therapeutics’ motion for a preliminary injunction, which Liquidia said would allow the FDA to grant final approval of the Yutrepia application.
Liquidia CEO Roger Jeffs commented, “We are pleased that the FDA agreed that our NDA amendment last July was proper, providing a clear path to full approval of Yutrepia in both PAH and PH-ILD. However, we are disappointed and disagree with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on May 23, 2022. We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to Yutrepia with the least delay possible.”
Read the Liquidia Corporation press release.
