According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia’s facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The company added that it has received notice that the agency will also require a pre-approval inspection of a contract facility that will provide filling and packaging services for the treprostinil DPI.
Liquidia resubmitted its 505(b)(2) NDA for LIQ861 in May 2021, and the FDA accepted the application for review in June 2021. The company first submitted the NDA in January 2020. The FDA accepted that application for review in April 2020 but was unable to conduct an inspection at that time due to the COVID-19 pandemic. The FDA issued a complete response letter to the initial NDA in November 2020.
In June 2020, United Therapeutics filed a patent infringement suit against Liquidia alleging infringement of patents covering Tyvaso inhalation solution. Earlier this year, United Therapeutics filed an NDA for Tyvaso DPI, its own treprostinil dry powder inhaler. The FDA accepted the Tyvaso DPI NDA for priority review in June 2021 and is expected to complete its review of the Tyvaso DPI NDA in October 2021.
Earlier this month, Liquidia announced that the the US Patent Trial and Appeal Board (PTAB) has initiated an inter partes review against an additional United Therapeutics patent covering Tyvaso (US Patent No. 10,716,793). The PTAB had previously instituted inter partes review against another Tyvaso patent (US Patent No. 9,604,901) in October 2020.
At the time, Liquidia CEO Damian deGoa commented, “The PTAB’s decision to institute an IPR against the ‘793 patent is another important step forward for Liquidia’s ongoing effort to bring LIQ861, a convenient and well tolerated inhaled dry powder formulation of treprostinil, to the PAH community. With a decision in the IPR for U.S. Patent No. 9,604,901 expected in October and our continued efforts in the ongoing litigation against United Therapeutics, we remain confident that the patents asserted against us will be found invalid and not infringed by Liquidia.”
In regards to the pre-approval inspection, deGoa said, “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.”
Liquidia Chief Operations Officer Robert Lippe said, “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 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.”
Read the Liquidia Corporation press release about the pre-approval inspection.
Read the Lliquidia Corporation press release about the inter partes review.
