MORRISVILLE, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) provided an update on its review of the New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

北卡罗来纳州莫里斯维尔，2024年1月25日（环球通讯社）--Liquidia Corporation（该公司）（纳斯达克：LQDA）今天宣布，美国食品和药物管理局（FDA）提供了对YUTREPIA新药申请（NDA）审查的最新情况™ （曲前列素）吸入粉末治疗肺动脉高压（PAH）和与间质性肺病（PH-ILD）相关的肺动脉高压。

The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA. Accordingly, the FDA is not able to issue an action letter in time to meet the previously issued Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024, and their review remains ongoing.

FDA告知该公司，它正在确认添加PH-ILD指示的过程，作为对YUTREPIA NDA的修订。因此，FDA无法及时发布行动信，以满足之前发布的《处方药用户费用法案》（PDUFA）2024年1月24日的目标日期，他们的审查仍在进行中。

The FDA did not request any additional clinical data to support the NDA and did not issue a new PDUFA goal date. Dr. Roger Jeffs, Chief Executive Officer, said: “We are in active communication with the FDA regarding the process we followed to amend our NDA to add PH-ILD to the labeled indication. Whether the NDA is amended or supplemented, we will continue to prepare for the final FDA approval of YUTREPIA to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso® on March 31, 2024.

FDA没有要求任何额外的临床数据来支持NDA，也没有发布新的PDUFA目标日期。首席执行官Roger Jeffs博士，他说：“我们正在与FDA积极沟通修订NDA以将PH-ILD添加到标记适应症中的过程。无论NDA是修订还是补充，我们都将继续准备FDA最终批准YUTREPIA在2024年3月31日Tyvaso®监管排他性到期后治疗PAH和PH-ILD患者。

As communicated by the tentative approval to treat PAH, YUTREPIA has already met the regulatory standards for quality, safety and efficacy. We remain committed to addressing the unmet needs across all patients whose lives may be improved by the unique benefits of YUTREPIA.” On November 5, 2021, the FDA issued a tentative approval for YUTREPIA for the treatment of PAH to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms.

根据初步批准治疗PAH的通知，YUTREPIA已经达到了质量，安全性和有效性的监管标准。我们仍然致力于解决所有患者的未满足需求，这些患者的生活可能会因YUTREPIA的独特益处而得到改善。”2021年11月5日，FDA暂时批准YUTREPIA治疗PAH，以改善纽约心脏协会（NYHA）功能性II-III级症状成年患者的运动能力。

In July 2023, Liquidia filed an am.

2023年7月，Liquidia提交了一份am。