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Liquidia Submits New Drug Application for LIQ861 (treprostinil) inhalation powder to U.S. Food and Drug Administration for the Treatment of Pulmonary Arterial Hypertension (PAH)
RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical
About this update from Liquidia Corporation
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development of products using its proprietary PRINT® technology, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LIQ861. LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using Liquidia’s PRINT® technology with the goal of enhancing deep-lung delivery using a convenient, palm-sized dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH). \n The NDA has been submitted under the 505(b)(2) regulatory pathway and includes data from three clinical studies to establish the safety, tolerability and pharmacokinetic profile of LIQ861. The open-label Phase 3 study, known as INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil) (NCT03399604), included 121 PAH patients who transitioned from stable doses of the reference listed drug or added LIQ861 to no more than two approved non-prostacyclin oral PAH therapies. The company also completed pharmacokinetic studies to establish the bioavailability of LIQ861 relative to the bioavailability of the reference listed drug. Neal Fowler, Chief Executive Officer of Liquidia, said, \"The submission of the NDA for LIQ861 in the U.S. is a significant milestone for our company and our goal to address an important unmet need in the delivery of inhaled therapy for PAH patients. We would like to sincerely thank the patients, their families and the clinical investigators for their participation in the LIQ861 clinical program, and we look forward to working closely with the FDA during the review process.” About LIQ861 LIQ861 is an investigational inhaled dry powder formulation of treprostinil designed using Liquidia’s PRINT® technology with the goal of enhancing deep-lung delivery using a convenient, palm-sized dry powder inhaler (“DPI”) for the treatment of pulmonary arterial hypertension (PAH). PRINT® technology enables development of drug particles that are precise and uniform in size, shape, weight and composition that are engineered for optimal deposition in the lung following oral inhalation. Liquidia believes LIQ861 can overcome the limitations of current inh...