ST LOUIS (MD Consult) - On September 11, 2009, Theravance and Astellas announced that the US Food and Drug Adminstration (FDA) has approved Vibativ (telavancin). Vibativ is a bactericidal, injectable, lipoglycopeptide antibiotic. It is indicated for the treatment of adults with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin susceptible [MSSA] and resistant [MRSA] isolates); Streptococcus pyogenes; Streptococcus agalactiae; Streptococcus anginosus group (includes S anginosus, S intermedius, and S constellatus); and Enterococcus faecalis (vancomycin susceptible isolates only).
The safety and efficacy of Vibativ were evaluated in 2 phase 3, multinational, double-blind, randomized trials. These studies were designed to compare the use of Vibativ (10 mg/kg intravenously [IV] once daily) with vancomycin (1 gm IV every 12 hours) in adult patients with cSSSI caused by gram-positive bacteria. A total of 1,867 patients were enrolled and treated in these studies, and 719 were experiencing infections caused by MRSA. In both studies, Vibativ achieved its primary end point of noninferiority relative to the standard of care, vancomycin. Vibativ has not been studied in children.
The most common adverse reactions (≥10% of patients treated with Vibativ) observed in the phase 3 cSSSI clinical trials were taste disturbance, nausea, vomiting, and foamy urine. In these trials, serious adverse events were reported in 7% of patients treated with Vibativ and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% of vancomycin-treated patients and most commonly included cardiac, respiratory, or infectious events.
Vibativ is administered once daily and should be infused over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause flushing of the upper body, urticaria, pruritus, or rash.
Vibativ will be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009.
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圣路易斯(MD Consult)——2009年9月11日，Theravance公司和安斯泰来制药公司宣布，美国食品药品管理局(FDA)已批准Vibativ (telavancin)。Vibativ是一种注射型脂糖肽类杀菌抗生素，适用于治疗由下列革兰氏阳性菌致病分离物所引起的成人复杂皮肤感染和皮肤结构感染(cSSSI)：金黄色葡萄球菌(包括甲氧西林敏感金黄色葡萄球菌[MSSA]和耐甲氧西林金黄色葡萄球菌分离物)；化脓性链球菌；无乳链球菌；咽峡炎链球菌属(包括咽峡炎链球菌、中间链球菌和星座链球菌)；以及粪肠球菌(仅对万古霉素敏感分离物)。
有2项3期多中心、双盲、随机试验对Vibativ的安全性和有效性做了评估。这些研究旨在比较成人cSSSI(系革兰氏阳性菌所致)患者应用Vibativ (10 mg/kg ，静脉给药，1日1次)与万古霉素(1 gm ，静脉给药，每12h 1次)疗效。共1,867例患者参加研究并接受治疗，719例当时患有MRSA感染。在这两项研究中，Vibativ达到其相对于标准治疗药万古霉素的非劣性主要研究终点。在儿童中尚未对Vibativ进行研究。
3期 cSSSI临床试验中最常见的不良反应(发生率在Vibativ治疗组患者中≥10%)为味觉障碍、恶心、呕吐、以及泡沫尿。在这些试验中，Vibativ治疗组中7%的患者报告发生严重的不良事件，以肾脏、呼吸系统或心脏事件为最多见。万古霉素治疗组中5%的患者报告了严重不良事件，以心脏、呼吸系统或感染事件为最多见。
Vibativ1日1次用药，输注时间应为60min，以减少输注相关反应的发生风险。快速静脉输注糖苷肽类抗菌药可导致上半身潮红、荨麻疹、瘙痒或皮疹。
Vibativ将由安斯泰来公司上市和销售，预计于2009年第四季度在美国上市。
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