Liquidia: FDA Issues CRL For LIQ861; CRL Focuses On Drug CMC, Device Biocompatibility Information

This post was originally published on this site

(RTTNews) – Liquidia Technologies, Inc., a unit of Liquidia Corp. (LQDA), has received a complete response letter from the FDA for the New Drug Application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension. 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 data pertaining to the drug product and device biocompatibility. The CRL did not cite the need to conduct further clinical studies.

Liquidia said the company does not believe that the items raised in the CRL will be a barrier to the ultimate approval of LIQ861. Liquidia believes the company can address the items raised in the CRL without delaying the otherwise projected launch timing of LIQ861 in the second half of 2022.

Bastion Balance Seoul, Korea.