Liquidia Announces FDA Acceptance of New Drug Application Resubmission for LIQ861 (treprostinil) Inhalation Powder
June 02 2021 - 7:00AM
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 7, 2021.
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.
About LIQ861LIQ861 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). 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.
About Liquidia CorporationLiquidia
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.
Contact InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
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