FDA To Review NDA For Liquidia's Yutrepia

(RTTNews) - Liquidia Corporation (LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's amendment to the tentatively approved new drug application for Yutrepia (treprostinil) inhalation powder in which the company is seeking to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label.

The FDA confirmed the type of resubmission as Class II and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024.

Dr. Rajeev Saggar, Chief Medical Officer of Liquidia, said: "We are pleased that the FDA has accepted the submission for review with a PDUFA goal date well in advance of the expiration in March 2024 of the new clinical investigation exclusivity granted to Tyvaso®. If this amendment is approved by FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH). "

The FDA tentatively approved Yutrepia to treat PAH in November 2021 and confirmed that the addition of the PH-ILD indication will not require any new clinical studies.