Benzinga | Aug 18, 2021 04:34PM EDT

FDA Completes On-site Pre-Approval Inspection Of Liquidia's Morrisville, North Carolina Facility

Liquidia Corporation (NASDAQ:LQDA) announced today that the U.S. Food and Drug Administration (FDA) has completed an on-site Pre-Approval Inspection (PAI) of its Morrisville, North Carolina facility in connection with the on-going review of the New Drug Application (NDA) for LIQ861 (treprostinil) inhalation powder. The 5-day PAI concluded on August 13 and no Form 483 Inspectional Observations were issued. This was Liquidia's first inspection of the Morrisville site by the FDA.



Robert Lippe, Chief Operations Officer at Liquidia, stated: "This is a very important element in our advancement of LIQ861 through the NDA process. In addition, we believe this favorable outcome from the first FDA inspection of our proprietary PRINT(r) technology helps demonstrate the potential for future applications of our precise, uniform drug particles across different types of molecules, therapeutic areas and routes of administration."

Damian deGoa, Chief Executive Officer at Liquidia, added: "We are pleased that it was possible to complete this inspection despite the challenges presented by the on-going COVID-19 pandemic. As a company, we will continue to build on the momentum of the completion of the PAI, alongside our successes in on-going litigation against United Therapeutics and the strong launch of our subcutaneous administration of Treprostinil Injection."

On June 2, 2021, the FDA accepted for review the NDA resubmission for LIQ861 (treprostinil) inhalation powder and under the Prescription Drug User Fee Act (PDUFA) set a goal date of November 7, 2021. The resubmitted NDA included additional information and clarification on chemistry, manufacturing, and controls (CMC) pertaining to the drug product as well as data on device biocompatibility. No additional data from clinical trials or studies related to toxicology or clinical pharmacology were required. The NDA has been submitted under the 505(b)(2) regulatory pathway and Tyvaso(r), a nebulized treprostinil solution, is the Reference Listed Drug for the LIQ861 NDA.

In July 2021, the Company received a notice from the FDA that, due to restrictions on travel related to COVID-19, the FDA may be unable to conduct pre-approval inspections prior to the PDUFA goal date. On August 6, 2021, the FDA notified Liquidia of the planned PAI of the Morrisville site beginning on August 9, 2021, which was concluded on August 13, 2021. In addition to the completed inspection of Liquidia's Morrisville site, the FDA has notified Liquidia that a PAI will also be required for the third-party provider of encapsulation and packaging services for LIQ861. At this time, the Company has not been notified of when this additional PAI may be completed.