According to Liquidia, the FDA has accepted the company’s resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the agency accepted the submission in April 2020 and then issued a complete response letter to the NDA in November 2020. The resubmission was filed in May 2021.
United Therapeutics filed a patent infringement suit against Liquidia in June 2020 in which it alleges infringement of patents covering Tyvaso inhalation solution and, in April 2021, filed an NDA for Tyvaso DPI, its own treprostinil dry powder inhaler.
Liquidia notes that, “Any final FDA approval of the NDA for LIQ861 would be subject to the resolution of the pending Hatch-Waxman litigation commenced by United Therapeutics, and also subject to the FDA’s consideration of developments that may have occurred since the time of the tentative approval. The FDA may not issue a final approval until the expiration of a 30-month regulatory stay in October 2022 or an earlier judgment unfavorable to United Therapeutics by the court.”
Read the Liquidia press release.
