Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE trial of LIQ861 had met its primary endpoint.
Liquidia CEO Neal Fowler commented, “The submission of the NDA for LIQ861 in the US is a significant milestone for our company and our goal to address an important unmet need in the delivery of inhaled therapy for PAH patients. We would like to sincerely thank the patients, their families and the clinical investigators for their participation in the LIQ861 clinical program, and we look forward to working closely with the FDA during the review process.”
Read the Liquidia Technologies press release.