Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for review in April 2020.
According to Liquidia, the letter cites “the need for additional information and clarification on chemistry, manufacturing and controls (CMC) data pertaining to the drug product and device biocompatibility” and does not ask for additional clinical trials. In addition, the letter notes that the FDA still needs to conduct pre-approval inspections of Liquidia manufacturing facilities, which have been delayed due to the COVID-19 pandemic.
The company said that it “does not believe that the items raised in the CRL will be a barrier to the ultimate approval of LIQ861” and does not expect any delays to its anticipated launch in the second half of 2022 if the NDA is approved.
Liquidia CEO Neal Fowler commented, “We remain very confident in LIQ861 and are committed to working closely with the FDA to address these items to support its approval. With more than 70 patients now having received LIQ861 for more than two years in our clinical trials, Liquidia remains committed to PAH patients who we believe are underserved with currently available treatment options.”
LIQ861 is also the subject of a patent infringement suit filed by United Therapeutics in June 2020 and amended in July 2020.
Read the Liquidia Technologies press release.
