Additional Relevant Details
In the CRL, the FDA stated that it is unable to approve the NDA at this time. The CRL identified the need for additional information and clarification on chemistry, manufacturing and controls (CMC) data pertaining to the drug product and device biocompatibility. Liquidia does not believe that the items raised in the CRL will be a barrier to the ultimate approval of LIQ861.
The FDA also reconfirmed the need to conduct on-site pre-approval inspections (PAIs) of two of Liquidia’s U.S. manufacturing facilities before the application can be approved. The FDA noted it had been unable to conduct these inspections during the initial review cycle due to COVID-19 related travel restrictions.
The CRL did not cite the need to conduct further clinical studies, nor did the FDA require additional studies related to toxicology or clinical pharmacology. Of note, Liquidia believes that it can address the items raised in the CRL without delaying the otherwise projected launch timing of LIQ861 in the second half of 2022, subject to FDA approval.