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Liquidia Submits Amendment to Add PH-ILD Indication to Tentatively Approved NDA for YUTREPIA™ (treprostinil) Inhalation Powder
No new clinical data is required to add PH-ILD indication as per FDA correspondenceRecertified that YUTREPIA does not infringe any valid patents listed in the
About this update from Liquidia Corporation
[{"type":"text","content":"No new clinical data is required to add PH-ILD indication as per FDA correspondenceRecertified that YUTREPIA does not infringe any valid patents listed in the Orange Book for TyvasoPreparing for potential launch of YUTREPIA between end of 2023 to mid-2024 MORRISVILLE, N.C., July 27, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today 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® expires 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 not infringed 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. Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: “We have submitted this request to ensure that patients may access YUTREPIA for both the PAH and PH-ILD indications as soon as possible. We continue to hear from the community that alternative inhaled products are needed, especially for those patients who may benefit from a low resistance dry powder inhaler that can be easily titrated to optimal therapeutic effect like YUTREPIA. This feedback reinforces our undeterred commitment to deliver on the full potential of YUTREPIA to improve patients’ lives.” About YUTREPIA™(treprostinil) inhalation powder YUTR...