FDA批准新型抗菌药物Vabomere

FDA approvesnew antibacterial drug

FDA批准新型抗菌药物

ForImmediate Release  August 29, 2017

2017.08.29

Release

发布

The U.S. Foodand Drug Administration today approved Vabomere for adults with complicatedurinary tract infecti** (cUTI), including a type of kidney infection,pyelonephritis, caused by specific bacteria. Vabomere is a drug containingmeropenem, an antibacterial, and vaborbac**, which inhibits certain types ofresistance mechanisms used by bacteria.

FDA今天批准了Vabomere，用于治疗**尿路感染(cUTI)-包括一种由特殊细菌感染引起的肾脏感染、肾盂肾炎。Vabomere是一种含有美罗培南、抗生素和vaborbac**的药物，能够抑制细菌使用的某些类型的抵抗机制。

“TheFDA is committed to making new safe and effective antibacterial drugsavailable,” said Edward Cox, M.D., director of the Office of AntimicrobialProducts in the FDA’s Center for Drug Evaluation and Research. “This approvalprovides an additional treatment option for patients with cUTI, a type ofserious bacterial infection.”

“FDA致力于生产新的安全有效的抗菌药物。”FDA药物评估和研究中心的抗菌产品办公室主任爱德华•考克斯说。该项批准为患有cUTI的病人提供了一项额外的治疗选择方案。

The safety andefficacy of Vabomere were evaluated in a clinical trial with 545 adults withcUTI, including those with pyelonephritis. At the end of intravenous treatmentwith Vabomere, approximately 98 percent of patients treated with Vabomerecompared with approximately 94 percent of patients treated withpiperacillin/tazobac**, another antibacterial drug, had cure/improvement insymptoms and a negative urine culture test. Approximately seven days aftercompleting treatment, approximately 77 percent of patients treated withVabomere compared with approximately 73 percent of patients treated withpiperacillin/tazobac** had resolved symptoms and a negative urine culture.

临床上通过对545例患有cUTIde（包括肾盂肾炎）病人进行试验来评估Vabomere的安全性和有效性。在静脉注射治疗的最后，大约98%的患者接受了Vabomere静脉注射的治疗，相比之下，大约94%的患者接受了吡哌拉唑/他唑巴坦的治疗（另一种抗菌药物，治疗、改善症状和尿液培养后显阴性）。完成治疗大约7天后，大约77%接受Vabomere静脉注射的治疗的患者症状得到了改善、尿液培养后显阴性，相比之下接受吡哌拉唑/他唑巴坦的治疗的患者大约是有73%的患者症状得到了改善、尿液培养后显阴性。

The mostcommon adverse reacti** in patients taking Vabomere were headache, infusi**ite reacti** and diarrhea. Vabomere is associated with serious risksincluding allergic reacti** and seizures. Vabomere should not be used inpatients with a history of anaphylaxis, a type of severe allergic reaction toproducts in the class of drugs called beta-lac**s.

最常见的不良反应是头痛、注射部位反应和腹泻。Vabomere涉及一些严重的风险，包括过敏反应和癫痫发作。不应该将Vabomere应用于有过敏史的病人身上，这是在一种叫做β-内酰胺类抗生素的药物中表现出来的严重过敏反应。

To reduce thedevelopment of drug-resistant bacteria and maintain the effectiveness ofantibacterial drugs, Vabomere should be used only to treat or preventinfecti** that are proven or strongly suspected to be caused by susceptiblebacteria.

为了减少耐药菌的发展，并保持抗菌药物的有效性，我们应该仅用它来治疗或预防那些被证实或被怀疑是由易感染细菌引起的感染。

Vabomere wasdesignated as a qualified infectious disease product (QIDP). This designation isgiven to antibacterial products that treat serious or life-threateninginfecti** under the Generating Antibiotic Incentives Now (GAIN) title of theFDA Safety and Innovation Act. As part of its QIDP designation, Vabomerereceived a priority review.  

Vabomere被指定为一种合格的治疗传染病产品(QIDP)。这一称号被授予了在目前(GAIN)FDA安全与创新法案的标题下，治疗严重或危及生命的感染的抗菌产品。作为QIDP的一部分，Vabomere获得了一项优先审评。

The FDAgranted approval of Vabomere to Rempex Pharmaceuticals.

FDA批准了RempexPharmaceuticals生产的Vabomere。