FDA Approves Melinta Antibiotic for Serious Skin Infections

FDA批准Melinta抗生素治疗严重皮肤感染

2021-03-17 11:30:10 BioSpace

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Antimicrobial resistance is a global problem. In a 2019 report by the U.S. Centers for Disease Control and Prevention (CDC), the agency stated that in the U.S. about 2 million people are infected each year with antibiotic-resistant bacteria and 23,000 people die as a result. A study the same year by the U.K. government estimated that by 2050, as many as 10 million people could die worldwide from antibiotic-resistant infections. So it’s certainly newsworthy when a new antibiotic is approved. The U.S. Food and Drug Administration (FDA) approved Melinta Therapeutics’ Kimyrsa (oritavancin) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). ABSSSI affects about 14 million patients in the U.S. annually, and are the cause of more than 3 million emergency room visits. The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion. It also has an oritavancin-based product on the market, Orbactiv, which was approved in 2014 as an alternative to vancomycin. Orbactive is infused over three hours. Vancomycin, for this indication, is infused twice a day for seven to 10 days. The approval of Kimyrsa was based on trials in almost 2,000 patients, which demonstrated the drug was as effective as vancomycin in treating MRSA. “The approval of Kimyrsa demonstrates Melinta’s commitment to provide innovative therapies to patients with acute and life-threatening illnesses,” said Christine Ann Miller, president and chief executive officer of Melinta. “We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time. We believe that with the approval of Kimyrsa and product availability this summer, physicians and patients will now have a compelling new one-dose alternative to the current standard of multi-dose regimens for ABSSSI.” The antibiotics business is notoriously difficult to make profitable, since it is primarily used for short-term treatments. Many biopharma companies have moved away from the antibiotics space. In February, Sandoz, a division of Swiss-based Novartis, inked a deal to buy UK-based GlaxoSmithKline’s cephalosporin antibiotics business. Under the terms of the deal, Sandoz paid GSK $350 million at closing and additional milestones up to $150 million. The agreement included global rights to three brands, Zinnat, Zinacef and Fortum in more than 100 countries. Some of those rights are excluded in the U.S., Australia and Germany, which were previously divested by GSK. Also, GSK is holding onto the rights to some brands in India, Pakistan, Egypt, Japan and China. “This important transaction will further position Sandoz as a global leader in antibiotics—truly essential medicines that are the backbone of modern healthcare systems,” said Richard Saynor, chief executive officer of Sandoz. “Cephalosporins are the largest antibiotic segment by global sales and acquiring this leading business, including the established global Zinnat brand, will complement our #1 position in generic penicillins, the other key segment. It will also set us up for additional synergies driven by an increased promotional footprint that will support growth of both the acquired brands and the current existing Sandoz portfolio.” On March 1, CorMedix received a Complete Response Letter (CRL) from the FDA for their New Drug Application (NDA) for DefenCath for the treatment of life-threatening bloodstream infections associated with the use of central venous catheters in patients receiving chronic hemodialysis. Defencath is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL. Taurolidine is an amino acid derivative that has broad antimicrobial activity against gram-positive and -negative bacteria, including antibiotic-resistant strains, in addition to mycobacteria and clinically relevant fungi including Aspergillus. The company also is working to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients. CorMedix indicated the FDA couldn’t approved the NDA in its present form. There were concerns at the third-party manufacturing facility after a records review, but no issues were specified. The agency did not request additional clinical data and did not identify any data-related deficiencies related to the efficacy or safety of Defencath. Most Read Today
抗菌药物耐药性是一个全球性的问题。美国疾病控制与预防中心(CDC)在2019年的一份报告中称,美国每年约有200万人感染抗生素耐药性细菌,2.3万人因此死亡。 同年英国的一项研究。美国政府估计,到2050年,全世界可能有多达1000万人死于抗生素耐药性感染。因此,当一种新的抗生素被批准时,肯定是有新闻价值的。 美国食品和药物管理局(FDA)批准Melinta Therapeutics的Kimyrsa(奥立他万星)用于治疗由指定革兰氏阳性微生物的易感分离物引起的急性细菌性皮肤和皮肤结构感染(ABSSI)的成人,包括耐甲氧西林金黄色葡萄球菌(MRSA)。在美国,每年约有1400万患者感染ABSSSI,超过300万人次的急诊室就诊是由ABSSSI引起的。 该药为脂糖肽类抗生素。它是在一次,一个小时的输注。它还在市场上有一种基于奥立他万星的产品,Orbactiv,它在2014年被批准作为万古霉素的替代品。轨道活动的输注超过三个小时。万古霉素,对于这个适应症,每天输注两次,持续七到十天。 Kimyrsa的批准是基于在近2000名患者中进行的试验,这些试验证明该药物在治疗MRSA方面与万古霉素一样有效。 Melinta公司总裁兼首席执行官Christine Ann Miller说:“Kimyrsa的批准表明Melinta公司致力于为急性和危及生命的疾病患者提供创新疗法。“我们已响应医学界的要求,提供一种输液时间更短的奥立他万星产品。我们相信,随着Kimyrsa的批准和今夏产品的上市,医生和患者现在将有一个令人信服的新的单剂量替代方案,以替代目前的多剂量治疗ABSSI的标准。“ 众所周知,抗生素业务很难盈利,因为它主要用于短期治疗。许多生物制药公司已经离开了抗生素领域。今年2月,瑞士诺华集团旗下的山德士公司签署了收购英国葛兰素史克公司头孢抗生素业务的协议。 根据交易条款,山德士在交易结束时向葛兰素史克支付3.5亿美元,其他里程碑最高可达1.5亿美元。该协议包括Zinnat、Zinacef和Fortum三个品牌在100多个国家的全球版权。其中一些权利在美国、澳大利亚和德国被排除在外,而这些权利此前已被葛兰素史克剥离。此外,葛兰素史克还持有印度、巴基斯坦、埃及、日本和中国的一些品牌的版权。 Sandoz公司首席执行官Richard Saynor说:“这一重要交易将进一步使Sandoz公司成为抗生素领域的全球领先者--抗生素是现代医疗保健系统的支柱,是真正的基本药物。”“头孢菌素是全球销售额最大的抗生素部门,收购这一领先业务,包括已建立的全球Zinnat品牌,将补充我们在非专利青霉素(另一个关键部门)的第一地位。它还将为我们提供额外的协同效应,这是由扩大的推广范围推动的,这将支持收购的品牌和现有的山德士产品组合的增长。“ 3月1日,CorMedix公司收到了FDA的一份完整的回复函(CRL),内容涉及他们针对DefenCath的新药申请(NDA)。该新药用于治疗慢性血液透析患者使用中心静脉导管引起的危及生命的血流感染。Defencath是一种专有配方,含有1.35%,柠檬酸盐3.5%,肝素1000单位/ml。牛磺罗定是一种氨基酸衍生物,对革兰氏阳性和阴性细菌(包括抗生素耐药菌株)、分枝杆菌和临床相关真菌(包括曲霉)具有广泛的抗菌活性。该公司还致力于开发Defencath作为一种用于肿瘤和全肠外营养患者的导管锁定解决方案。 CorMedix表示,FDA不能批准目前形式的NDA。在记录审查后,第三方制造设施存在问题,但没有具体说明问题。该机构没有要求提供更多的临床数据,也没有发现与Defencath的疗效或安全性有关的任何数据相关的缺陷。 今天阅读最多的

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