According to Liquidia, the FDA has tentatively approved the company’s NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to the NDA in November 2020. Liquidia refiled the LIQ861 NDA in May 2021, and in August 2021, the agency completed a pre-approval inspection of the company’s manufacturing facility.
The approval cannot be finalized until settlement of a patent infringement suit filed by United Therapeutics in June 2020 or until a regulatory stay expires on October 27, 2022, whichever comes first. United Therapeutics also wants to market a treprostinil DPI for the treatment of PAH, having licensed Treprostinil Technosphere from MannKind in September 2018. The FDA accepted United Therapeutics’ NDA for Tyvaso DPI for priority review in June 2021 and issued a CRL to that application in October 2021.
Liquidia Chief Medical Officer Tushar Shah commented, “We would like to take the opportunity to thank the patients and investigators who participated in the clinical development of Yutrepia. The tentative approval for Yutrepia is another step toward providing an important option for patients with PAH in the US. We believe Yutrepia can improve the limitations of current nebulized therapies by allowing the administration of an expanded dose range of inhaled treprostinil using a proven, convenient, palm-sized device.”
CEO Damian deGoa said, “This is a significant milestone for Liquidia. We are really proud of our team. Not only does the tentative approval establish the safety and efficacy of Yutrepia for PAH patients but, in the process, we have validated our proprietary PRINT technology to engineer discrete drug particles with uniform composition, size, and shape. There is more work to be done. We will now focus our efforts on pre-commercial launch activities and the growing market opportunity for Yutrepia in PAH and potential new indications.”
Read the Liquidia press release.
