FDA needs more info before approving new drug application for Liquidia

RESEARCH TRIANGLE PARK – Shares in Liqudia (Nasdaq: LQDA) declined more than 6% early Wednesday when the life science firm says the FDA did not approve its new drug application for a treatment of pulmonary arterial hypertension.

The full announcement follows:

Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia Corporation (NASDAQ: LQDA), today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s New Drug Application (NDA) for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH).

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.

“We remain very confident in LIQ861 and are committed to working closely with the FDA to address these items to support its approval,” said Neal Fowler, Chief Executive Officer at Liquidia. “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.”