Amoxicillin/Clarithromycin/Vonoprazan

FLORHAM PARK, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced regulatory updates for its approved products, VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA DUAL PAK™, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis. Phathom has received complete response letters from the U.S. Food and Drug Administration (FDA) relating to its erosive esophagitis NDA and H. pylori post approval supplement, both of which address specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP), that was detected in the initial commercial launch materials of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. These letters formalize FDA’s request, announced by the Company last month, that Phathom provide additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product. No additional deficiencies were cited by the FDA in either letter. Phathom has conducted extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of NVP below the acceptable intake. Phathom expects to meet with the FDA in the first quarter of this year to discuss the resubmission plan and timeline that the Company believes will lead to approval and launch of products containing vonoprazan. “We remain encouraged with the progress we have made in generating additional stability data to meet FDA’s request and are eagerly awaiting our meeting with the FDA anticipated later this quarter to discuss our ongoing efforts, share our data, and gain alignment on resubmission and potential approval timelines,” said Terrie Curran, President and Chief Executive Officer of Phathom. “We are pleased that no other review issues were cited related to our erosive esophagitis NDA and that our labeling discussions continued to progress since our announcement last month, resulting in a near final label. We are confident that our ongoing stability program will generate the required data and will clear the pathway to potential approval and launch of these important products for patients in need of new treatment options for erosive esophagitis and H. pylori infection.” About Phathom Pharmaceuticals, Inc. Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). For more information about Phathom, visit the Company’s website at and follow the Company on LinkedIn and Twitter. Forward-Looking Statements Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding Phathom’s expectations of generating stability data necessary to support the proposed shelf life of vonoprazan and the potential approval of its erosive esophagitis NDA and post approval supplement for its H. pylori NDAs, and anticipated product launches in H. pylori and erosive esophagitis. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: Phathom may be unable to generate the required data to meet the acceptable intake (AI) of its nitrosamine impurity, or may be unable to reduce the impurity to an acceptable level throughout the shelf life of the product, to obtain approval for its erosive esophagitis NDA or to bring vonoprazan to market for patients with erosive esophagitis, if approved, or for patients with H. pylori; risks associated with product manufacturing or formulation changes required to be made in connection with achieving the AI; the FDA may disagree that the existing safety and efficacy data, together with additional data, is sufficient to approve the erosive esophagitis NDA or supplements to the H. pylori NDAs; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions; Phathom’s ability to obtain and maintain intellectual property protection for vonoprazan; Phathom’s ability to comply with its license agreement with Takeda; Phathom’s ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. MEDIA CONTACT Nick Benedetto 1-877-742-8466 media@phathompharma.com INVESTOR CONTACT Eric Sciorilli 1-877-742-8466 ir@phathompharma.com

导语：2023新年之际，美国FDA药品评价和研究中心（CDER）发布了2022年度的新药获批报告。在过去的一年里，CDER一共批准了37款新药。过去10年里，CDER平均每年批准43款新药。2022年，CDER批准了37种以前从未在美国批准或上市的新药，被称为“新型”药物。包括新药批准和在新环境中批准的药物，针对的是以下疾病和病症：■ 传染病，包括COVID-19、HIV、天花、流感和幽门螺杆菌感染，这是一种胃部细菌感染。 ■ 神经系统疾病，例如肌萎缩侧索硬化症和脊髓性肌萎缩症。■ 心脏、血液、肾脏和内分泌疾病，例如1型糖尿病和2型糖尿病、一种贫血、各种肾损伤和慢性体重管理。■ 自身免疫、炎症和肺部疾病，例如炎症性肠病、营养缺乏、狼疮性肾炎、关节炎、嗜酸性粒细胞性食管炎（一种慢性炎症性疾病）和牛皮癣。■ 不同类型的癌症，例如肺癌、前列腺癌、各种类型的乳腺癌、一种称为PROS 的罕见过度生长综合征和黑色素瘤。罕见病患者的新药患有罕见疾病的患者通常急需新疗法，因为这些患者通常没有现有的治疗选择。2022年，37种新药中有20种（占新药批准的54%）用于罕见病，包括：■ 酸性鞘磷脂酶缺乏症，一种影响身体代谢脂肪能力的遗传性疾病。■ 全身性脓疱性牛皮癣，一种罕见的危及生命的皮肤病。■ 阻塞性肥厚性心肌病，一种心肌增厚的疾病。■ 转移性或不可切除的葡萄膜黑色素瘤，一种罕见的癌症，发生在称为葡萄膜的眼睛的一部分。■ 肝肾综合征，晚期肝病患者肾功能受损的一种形式。First-in-Class药品CDER将2022年批准的37种新药中的20种（54%）确定为同类最优药物。这些药物的作用机制不同于现有疗法。2022年获批的CDER认定为first-in-class的新药有：Camzyos、Elahere、Enjaymo、Kimmtrak、Lunsumio、Mounjaro、Opdualag、Pluvicto、Pyrukynd、Sotyktu、Spevigo、Sunlenca、Tecvayli、Terlivaz、Tzield、Voquezna Triple Pak、Vtama、Xenoview、Xenpozyme、Ztalmy值得特别关注的first-in-class的药物如下：■ Camzyos(mavacamten)胶囊可改善一种阻塞性肥厚型心肌病患者的功能能力和症状，在这种情况下，心肌会变厚，从而更难泵血。■ Mounjaro（tirzepatide）注射剂作为饮食和运动的补充，可改善成人2型糖尿病患者的血糖控制。Mounjaro是一种一流的药物，可激活两种激素受体，从而改善血糖控制。■ Pluvicto（vipivotide tetraxetan）注射液用于治疗患有前列腺特异性、膜阳性、转移性、去势抵抗（尽管睾酮量减少但癌症仍在生长）前列腺癌的成人，这些前列腺癌之前至少接受过两种治疗，包括化疗。■ Sunlenca（lenacapavir）片剂和注射剂，适用于以前接受过多种HIV治疗且由于耐药性、不耐受性或安全问题而无法使用其他可用药物治疗的HIV成人患者。患者完成Sunlenca的起始剂量后，他们每六个月接受一次注射。患者接受 Sunlenca与其他抗逆转录病毒药物的联合治疗。■ Tzield(teplizumab-mzwv)注射液可延缓成人和8岁及以上患有2期1型糖尿病的儿科患者 3 期 1 型糖尿病的发作。Tzield是第一个被批准用于该适应症的药物。 ■ Voquezna Triple Pak（沃诺拉赞、阿莫西林和克拉霉素）和Voquezna Dual Pak（沃诺拉赞和阿莫西林）是联合包装的产品，包含片剂和胶囊的组合，用于治疗成人幽门螺杆菌感染，这是一种胃部细菌感染。 罕见病药物2022年，CDER批准的37种新药中有20种(54%) 被批准用于治疗罕见或“孤儿”疾病（在美国影响不到20万人的疾病）。患有罕见疾病的患者通常很少或根本没有可用于治疗其疾病的药物。2022年获批的孤儿药新药有：Amvuttra、Camzyos、Elahere、Enjaymo、Imjudo、Kimmtrak、Krazati、Lunsumio、Lytgobi、NexoBrid、Opdualag、Pyrukynd、Relyvrio、Rezlidhia、Spevigo、Tecvayli、Terlivaz、Vonjo、Xenpozyme、Ztalmy2022年新批准的罕见病案例包括：■ Amvuttra(vutrisiran)注射剂用于治疗患有遗传性转甲状腺素蛋白介导的淀粉样变性成人的多发性神经病（全身多条神经受损），这种疾病会导致器官和组织功能障碍。■ Elahere(mirvetuximab soravtansine-gynx)注射液用于治疗对铂类疗法耐药的复发性卵巢癌患者。■ Enjaymo(sutimlimab-jome)注射液可减少患有冷凝集素病（一种罕见的贫血）的成人因溶血（红细胞破坏）而需要输注红细胞。■ Imjudo(tremelimumab-actl)注射剂与Imfinzi一起治疗不可切除的肝细胞癌，这是最常见的肝癌类型。■ Kimmtrak(tebentafusp-tebn)注射剂是转移性或不可切除的葡萄膜黑色素瘤的第一种疗法，这是一种罕见的癌症，发生在称为葡萄膜的眼睛的一部分。■ Lunsumio(mosunetuzumab-axgb)注射液用于治疗患有复发性或难治性滤泡性淋巴瘤（一种非霍奇金淋巴瘤）的成人。Lunsumio通过加速审批程序获得批准。■ Opdualag（nivolumab和relatlimab-rmbw）注射液用于治疗12岁或以上患有转移性或不可切除的黑色素瘤的患者。■ Pyrukynd(mitapivat)片剂用于治疗患有丙酮酸激酶缺乏症的成人溶血性贫血（一种红细胞破坏速度快于制造速度的疾病），这是一种导致红细胞过早破坏的遗传性疾病。■ Relyvrio（牛磺草二醇和苯基丁酸钠）粉末用于治疗肌萎缩侧索硬化症(ALS) 的口服溶液，这是一种影响大脑和脊髓神经细胞的进行性神经退行性疾病。■ Spevigo(spesolimab-sbzo)注射剂用于治疗成人泛发性脓疱型银屑病发作。。Spevigo是第一个被批准用于治疗这种疾病的药物。■ Tecvayli(teclistamab-cqyv)注射液用于治疗既往至少接受过四次治疗的复发难治性多发性骨髓瘤成人患者。Tecyayli通过加速批准计划获得批准。■ Terlivaz（特利加压素）注射剂可改善肝肾综合征成人的肾功能，肝肾综合征是晚期肝病患者肾功能受损的一种罕见形式。Terlivaz是第一个被批准用于治疗这种情况的药物。 ■ Vonjo（pacritinib）胶囊用于治疗患有罕见骨髓疾病（称为中度或高危原发性或继发性骨髓纤维化）且血小板（凝血细胞）水平低于50,000/µL的成年人。Vonjo通过加速审批程序获得批准。■ Xenpozyme（olipudase alfa-rpcp）输液治疗酸性鞘磷脂酶缺乏症（尼曼匹克病A、B、A/B 型）的非中枢神经系统表现。这是针对这种影响人体代谢脂肪能力并可能影响肺、肝和脾的遗传性疾病的首次治疗。■ Ztalmy（加奈索酮）口服混悬液用于治疗两岁及以上患者与细胞周期蛋白依赖性激酶样5缺陷症 (CDD) 相关的癫痫发作。这是第一种针对与CDD相关的癫痫发作的治疗方法，也是第一种专门针对CDD的治疗方法，CDD是一种由基因突变引起的脑功能障碍。其他新药批准除了first-in-class和罕见病药物外，CDER在2022年还批准了这些值得注意的批准：■ Cibinqo（abrocitinib）片剂用于治疗难以控制的中度至重度特应性皮炎（湿疹）。■ Vtama(tapinarof)用于局部治疗患有斑块状牛皮癣的成人，这种情况会导致皮肤干燥、发痒、凸起。展望2023年，我们期待见证更多创新疗法获批，为全球患者带来新的治疗方案和希望。撰文|乔维钧排版|文竞择End参考资料：[1]https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022[2]https://www.fda.gov/media/164429/download 本文系生物探索原创，欢迎个人转发分享。其他任何媒体、网站如需转载，须在正文前注明来源生物探索。 往期精选 围观 新冠XBB的新加坡经验：再感染风险高，毒性低，疫苗及抗体药物无效 热文 全球新冠后遗症患者预计近1.45亿，“阳康”后还要警惕这些「新冠后遗症」！ 热文 ‍从艾滋病“跨行”治疗新冠的阿兹夫定安全有效，已覆盖上海115家医院 热文 “一生好强”的卵子，为了后代，努力修复辐射损伤的精子DNA 热文 中国抗癌药再出海！协议总金额高达95亿美元！ 点击“阅读原文”，了解更多~