Liquidia submits amendment to NDA for YUTREPIA inhalation powder

Liquidia announced the submission of an amendment to the tentatively approved new drug application for YUTREPIA inhalation powder to add the treatment of pulmonary hypertension associated with interstitial lung disease. The U.S. FDA has previously confirmed in writing that the addition of the PH-ILD indication will not require any new clinical information. Upon acceptance of the amendment, the FDA will confirm the type of resubmission as Class 1 or Class 2. If approved by FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension. The FDA can grant final approval of the PH-ILD indication in the YUTREPIA label after the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024.