New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for VOQUEZNA® as a daily treatment for heartburn associated with Non-Erosive GERD, the largest subcategory of GERDJuly 19, 2024 PDUFA target action date assigned by the FDA FLORHAM PARK, N.J., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc.

新药申请（NDA）寻求美国食品和药物管理局（FDA）批准VOQUEZNA®作为与非糜烂性GERD相关的胃灼热的日常治疗药物，这是GERDJuly 192024 PDUFA目标行动日期的最大子类别，由FDA FLORHAM PARK，N.J.，2023年12月6日指定（全球通讯社）-Phatom Pharmaceuticals，Inc。

(Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the FDA has accepted for review the company’s NDA for VOQUEZNA (vonoprazan) as a daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults.

（纳斯达克：PHAT）是一家专注于开发和商业化胃肠道疾病新型治疗方法的生物制药公司，今天宣布，FDA已接受该公司针对VOQUEZNA（vonoprazan）的NDA审查，作为与成人非糜烂性胃食管反流病（GERD）相关的胃灼热的日常治疗方法。

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024. 'Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA's acceptance for filing of our New Drug Application for VOQUEZNA as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom.

美国食品和药物管理局（FDA）已为该申请分配了一项为期10个月的标准审查，处方药用户费用法案（PDUFA）的目标行动日期为2024年7月19日。”Phathom首席运营官Azmi Nabulsi医学博士说：“今天标志着Phathom Pharmaceuticals迈出了重要的一步，因为我们宣布FDA接受提交我们的VOQUEZNA新药申请，作为非糜烂性GERD患者胃灼热的日常治疗方法。”。

“Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive Phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies.

“非糜烂性GERD代表了美国GERD人群的很大一部分，影响了数百万人，并影响了他们的生活质量。我们监管应用中的支持性数据包括PHALCON-NERD-301试验的阳性3期结果，以及与先前研究一致的安全性概况。

We look forward to working closely with the FDA throughout the review process and if approved, expect to launch VOQUEZNA for this new indication in the third quarter of 2024.” Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions.

我们期待在整个审查过程中与FDA密切合作，如果获得批准，预计将在2024年第三季度推出VOQUEZNA用于这一新适应症。“非糜烂性GERD是GERD的最大亚类，其特征是在没有食管粘膜糜烂的情况下出现反流相关症状。

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