美国食品和药物管理局批准了Liquidia的YUTREPIA,等待Tyvaso DPI专属权的到期. FDA grants tentative approval to Liquidia's YUTREPIA, pending expiration of Tyvaso DPI exclusivity.

利基迪亚公司的股票下跌近22%,此前FDA批准了其吸入粉末YUTREPIA,用于治疗肺动脉高血压 (PAH) 和肺高血压 (PH-ILD) 的成年人. Liquidia Corp's stock dropped nearly 22% after the FDA granted a tentative approval for its inhalation powder, YUTREPIA, to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH-ILD). 暂定批准表明YUTREPIA符合所有监管标准,但必须等待竞争产品Tyvaso DPI的监管专有权到期,才能获得最终批准. The tentative approval indicates that YUTREPIA has met all regulatory standards but must await the expiration of regulatory exclusivity of a competing product, United Therapeutics' Tyvaso DPI, before final approval can be granted. 预计2025年5月23日Tyvaso DPI三年监管专属权到期后,YUTREPIA最终批准PAH和PH-ILD。 The final approval for YUTREPIA for PAH and PH-ILD is expected after the expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025. 利基迪亚的首席执行官罗杰·杰夫斯对FDA决定授予联合治疗公司对Tyvaso DPI的监管独家权表示失望,并计划迅速采取行动挑战这一决定,并捍卫患者尽快获得YUTREPIA的能力. Liquidia's CEO, Roger Jeffs, expressed disappointment with the FDA's decision to grant regulatory exclusivity to United Therapeutics for Tyvaso DPI and plans to take quick action to challenge the decision and defend the ability for patients to have access to YUTREPIA with the least delay possible.