Liquidia has announced the resubmission of its NDA for LIQ861 dry powder treprostinil for the treatment of pulmonary arterial hypertension, with the addition of CMC and device data requested by the FDA. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the FDA accepted the submission for review in April 2020; and in November 2020, the agency issued a complete response letter to the NDA.
The company says that it held a Type A meeting with the FDA in January 2021 to clarify what additional information was required for the NDA and that it expects the modified application to be classified as a Class 2 resubmission. According to Liquidia, the agency also plans to conduct a pre-approval inspection, which it was unable to do when the initial NDA was submitted due to the COVID-19 pandemic.
Liquidia CEO Damian deGoa commented, “The team has worked hard to provide a comprehensive and rapid response to the CRL. We look forward to working with the FDA through the review process during the coming months.”
In June 2020, United Therapeutics filed suit against Liquidia alleging infringement of patents covering Tyvaso inhalation solution, and then it amended the suit in July 2020 after receiving an additional patent for Tyvaso. Earlier this year, United Therapeutics filed an NDA for its own treprostinil dry powder inhaler, Tyvaso DPI.
Read the Liquidia press release.
