FDA Wants More CMC Info for Liquidia LIQ861

In a complete response letter, FDA has informed Liquidia Technologies that it cannot approve the company’s NDA for its LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension. The company says FDA indicated a need for additional information and clarification on chemistry, manufacturing, and controls data on the drug product and device biocompatibility.

Liquidia officials say they don’t believe the items raised in the letter will be a barrier to the ultimate approval of LIQ861.

FDA also reconfirmed the need to conduct on-site pre-approval inspections of two of the company’s U.S. manufacturing facilities before the NDA can be approved. The agency has been unable to conduct the inspections during the Covid-19 pandemic.

Liquidia says FDA did not require further clinical studies and did not require additional studies related to toxicology or clinical pharmacology.