Liquidia Corporation announced the submission of an amendment to the tentatively approved new drug application (NDA) for YUTREPIA?? (treprostinil) inhalation powder to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The U.S. Food and Drug Administration (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 (PAH). The FDA can grant final approval of the PH-ILD indication in the YUTREPIA label after the new clinical investigation exclusivity granted to Tyvaso®? expands on March 31, 2024.

Concurrent with the amendment, Liquidia recertified under 21 U.S.C. 355(b)(2)(A)(iv), also referred to as paragraph IV certification, that the patents listed for Tyvaso®? in the FDA's publication of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, are invalid and/or notinfringed by YUTREPIA. All Orange Book patents previously asserted by United Therapeutics have already been found to be invalid or not-infringed as decided by U.S. District Court, confirmed on appeal, or by the Patent Trial and Appeal Board (PTAB), pending appeal.