Full Press Release Details
Announces FDA Acceptance of New Drug Application Resubmission
for LIQ861 (treprostinil) Inhalation Powder
MORRISVILLE, N.C., June 2, 2021 - Liquidia
Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA)
resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The FDA confirmed that the resubmission
was a complete, class 2 response to the previous action letter issued on November 24, 2020. The FDA set a PDUFA goal date of November
If the FDA determines, following its
substantive review of the NDA, that all requirements for approval have been met, the FDA may issue tentative approval on a timeline generally
informed by the PDUFA goal date. 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. A new drug product may not be marketed until the
date of final approval which is confirmed by the FDA at the time of final submission.
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).
PRINT technology enables the development of drug particles that are precise and uniform in size, shape and composition, and that
are engineered for optimal deposition in the lung following oral inhalation. Liquidia believes LIQ861 can overcome the limitations of
current inhaled therapies and has the potential to maximize the therapeutic benefits of treprostinil in treating PAH by safely delivering
higher doses into the lungs. Liquidia has completed an open-label, multi-center phase 3 clinical study of LIQ861 in patients diagnosed
with PAH known as INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil.
Liquidia Corporation
is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications
of its PRINT Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia
PAH, LLC. Liquidia Technologies is developing LIQ861, an inhaled dry powder formulation of treprostinil for the treatment of pulmonary
arterial hypertension (PAH). Liquidia PAH provides the commercialization for rare disease pharmaceutical products, such as generic Treprostinil
Injection. For more information, please visit www.liquidia.com.
Vice President, Corporate Development and Strategy