FDA批准Zerbaxa用于治疗复杂性尿路感染和腹腔感染

2014年12月19日美国食品和药品管理局（FDA）公布已批准Zerbaxa【ceftolozane（头孢菌素）和他唑巴坦（β-内酰胺酶抑制剂）复合静脉制剂】用于治疗成人复杂性腹腔感染和复杂性尿路感染。该药物由Cubist制药负责上市和销售。

FDA声明指出，这是2014年FDA批准的第4个抗菌药物，与其他3个药物一样，它被指定为合格感染性疾病产品（QIDP）并给予优先审核。 Zerbaxa在FDA《安全与创新法案》的《立即建立抗菌素激励机制（GAIN）法案》下被指定为QIDP，“因为它是一种用于治疗严重的或危及生命的感染的抗菌或抗真菌人体用药，”。

作为QIDP项目的一部分，制造商也获得FDA准予的额外5年“排他”特权，即独家销售权。

Ceftolozane/他唑巴坦被批准用于联合甲硝唑治疗复杂性腹腔感染；该项适应症的批准是基于一项纳入979例患者并被随机分配至联合治疗组和美罗培南组的研究结果。批准用于治疗复杂性尿路感染（包括肾盂肾炎）则是基于一项纳入了1068例成人患者并被随机分配到Ceftolozane/他唑巴坦治疗组和左氧氟沙星治疗组的研究结果。

说明书中包含了一项肾功能不全患者（基线肌酐清除率≤30-50 mL/min）疗效下降的警告，并建议至少每日监测肾功能变化患者的肌酐清除率，并相应地调整剂量。F DA在声明中提到，研究中最常见的不良事件为恶心、腹泻、头痛、发热。

2014年FDA批准的其他抗菌药物的适应症为急性细菌性皮肤感染和由某些敏感细菌引起的皮肤组织感染，他们分别是5月被批准的达巴万星（Dalvance），6月被批准的tedizolid（Sivextro）和8月被批准的奥利万星（Orbactiv）。

爱思唯尔版权所有  未经授权请勿转载

By: ELIZABETH MECHCATIE, Ob.Gyn. News Digital Network

A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.

The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.

This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.

As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.

Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.

Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.

The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.

The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.