Benzinga | May 10, 2021 06:31AM EDT

Liquidia Resubmits New Drug Application for LIQ861 Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension

Liquidia Corporation (NASDAQ:LQDA) announced today that on May 7, 2021, it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the NDA in November 2020 indicating that the application was incomplete and not ready for approval in its present form. Liquidia and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission.



The resubmitted NDA includes additional information and clarification on chemistry, manufacturing, and controls (CMC) pertaining to the drug product as well as data on device biocompatibility. No additional data from clinical trials or studies related to toxicology or clinical pharmacology was required. The Company anticipates that the FDA will classify the resubmitted NDA, if accepted, as a Class 2 Resubmission, which would result in a six-month review cycle from the date of resubmission.