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Phathom Pharmaceuticals宣布Voquezna获得FDA批准

FDA Approves Voquezna

Drugs 等信源发布 2023-11-02 22:58

可切换为仅中文


FDA Approves Voquezna (vonoprazan) for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in AdultsFLORHAM PARK, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today the U.S.

FDA批准Voquezna(vonoprazan)用于治疗成人糜烂性GERD和缓解与糜烂性GERD相关的胃灼热Florham PARK,N.J.,2023年11月1日(GLOBE NEWSWIRE)-Phathom Pharmaceuticals,Inc。(纳斯达克股票代码:PHAT),一家专注于开发和商业化胃肠道(GI)疾病新疗法的生物制药公司,今天美国宣布。

Food and Drug Administration (FDA) has approved Voquezna® (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), maintenance of healing of all grades of Erosive GERD, and relief of heartburn associated with Erosive GERD.2 “This approval demonstrates Phathom's commitment to changing the GI treatment landscape for patients and healthcare providers, bringing the first major innovation to the U.S.

美国食品和药物管理局(FDA)已批准Voquezna®(vonoprazan)片剂10 mg和20 mg,一种新型钾竞争性酸阻断剂(PCAB),作为成人治疗各种糜烂性食管炎的新疗法,也称为糜烂性GERD(胃食管反流病),维持所有级别糜烂性GERD的愈合,和缓解与糜烂性GERD相关的胃灼热.2“这一批准表明Phatom致力于改变患者和医疗保健提供者的GI治疗环境,为美国带来第一项重大创新。

Erosive GERD market in over 30 years,” said Terrie Curran, President and Chief Executive Officer at Phathom. “Erosive GERD can be extremely painful and often has a significant impact on patients. Research has shown patients and healthcare providers are largely unsatisfied with current treatments and we are excited about the approval of a first-in-class treatment option that has the potential to meet a large unmet medical need.”Erosive GERD, also referred to as Erosive Esophagitis or Erosive Acid Reflux, is a major type of GERD that affects approximately 20 million people in the U.S.3,4 In addition to experiencing troubling heartburn symptoms, patients with inadequately treated Erosive GERD may develop more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer.3This appro.

Phathom总裁兼首席执行官Terrie Curran说,30多年来,侵蚀性的GERD市场。“侵蚀性GERD可能非常痛苦,并且通常会对患者产生重大影响。研究表明,患者和医疗保健提供者对目前的治疗方法基本上不满意,我们对批准一流的治疗方案感到兴奋。满足巨大的未满足的医疗需求。”侵蚀性GERD,也称为糜烂性食管炎或糜烂性酸反流,是一种主要类型的GERD,影响美国约2000万人.3,4除了经历令人不安的胃灼热症状外,糜烂性GERD治疗不足的患者可能会患上更严重的疾病,包括Barrett食管,食管组织改变可能发展为癌症的疾病.3这一观点。