Liquidia Technologies said that the FDA accepted the company’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA goal date of November 24, 2020. The company announced in March 2019 that the Phase 3 INSPIRE study of the LIQ861 DPI for PAH had met its primary endpoint and then in January 2020 announced that it had submitted the NDA.
The dry powder formulation is based on Liquidia’s PRINT particle engineering technology. According to the company’s web site, LIQ861 is currently the only inhaled drug in Liquidia’s pipeline; however in June 2019, the company announced amendments to an earlier collaboration agreement with GSK; the updated deal gives Liquidia development and commercialization rights to three PRINT-based inhalation products developed by GSK.
Liquidia CEO Neal Fowler commented, “FDA acceptance of this NDA is a significant milestone for our company and our PRINT technology. PRINT was the cornerstone that allowed for the precise engineering and development of LIQ861 into its current form and serves as the foundation for all of our products in development. If approved, LIQ861 will represent an important step forward in addressing the unmet needs of PAH patients by providing a convenient alternative to existing therapies. We look forward to working closely with the FDA through the NDA review process.”
Read the Liquidia Technologies press release.
