Theravance公司宣传美国食品和药物管理局接受了他们的一项申请，主要是关于telavancin治疗复杂性皮肤感性疾病。Telavancin是一种新型的具有杀菌作用，每日一次的注射药物，目前主要使用于治疗皮肤感性和由革兰阳性菌引起的医院获得性肺炎，包括耐药菌属如青霉素类抵抗性葡萄球菌属。

　　“我们期待着更高级的申请” 执行主管Rick E说到，“我们将继续与FDA合作，最终完善试验，并真正的把Telavancin应用到那些患者身上。”

　　Telavancin简介：

　　Telavancin是一种具有杀菌作用，每天一次可以注射的药物，该药目前处于调查研究阶段，具有多种作用机制。该药是Theravance公司在一项寻找新型抗菌药物的研究计划时发现的，该项研究计划目的是找到新型的能治疗由金黄色葡萄球菌(包括甲氧西林耐药金黄色葡萄球菌和革兰阳性细菌)引起的严重感染性疾病。该药能抑制细菌细胞壁并且能破坏细菌细胞膜。Theravance认为这些作用机制一方面可以起到杀菌作用，另一方面可以降低细菌产生耐药性作用。该公司已经开展了两项临床试验，其结果显示该药具有很好的疗效，因此该公司向FDA递交了两项新药申请，目前正处于审核阶段。

Indication(s):

Complicated skin and skin structure infections due to susceptible gram (+) bacteria.

Pharmacology:

Telavancin is a synthetic derivative of vancomycin that exerts its antibacterial effect by inhibiting bacterial cell wall synthesis and disrupting the functioning of the cell membrane. It has been shown to be effective against most isolates of Staphylococcus aureus (including methicillin-resistant strains, or MRSA), Streptococcus pyogenes, S. agalactiae, S. anginosus group, E. faecalis (vancomycin-susceptible strains only).

The use of telavancin should be avoided in patients who are pregnant, unless the benefits to the patient outweighs the potential risks to the fetus (eg, skeletal malformations).

Clinical Trials:

Telavancin (10mg/kg daily) was compared to vancomycin (1g every 12 hrs) in two randomized, multinational, double-blind studies in adults with clinically documented complicated skin and skin structure infections with MRSA suspected or confirmed as the primary pathogen. Patients could receive concomitant aztreonam or metronidazole for suspected gram (–) or anaerobic infections, respectively. The all-treated efficacy (ATe) population included all patients who received any amount of study drug and were evaluated for efficacy; the clinically evaluable (CE) population included those patients in the ATe group with sufficient adherence to protocol.

Of 1794 ATe patients, 1410 were clinically evaluable. The primary efficacy endpoint for each trial was the clinical cure rate at a followup visit in the ATe and CE populations. The clinical cure rates for the ATe populations in Trial 1 and Trial 2 were 72.5% and 74.7%, respectively, for telavancin, compared with 71.6% and 74.0% for vancomycin. The clinical cure rates for telavancin in the CE populations for the two trials were 84.3% and 83.9%, respectively, compared with 82.8% and 87.7% for vancomycin. The clinical cure rate for MRSA for telavancin was 87.0% compared to 85.9% for vancomycin.

Legal Classification:

Rx

Adults:

≥18yrs: Give by IV infusion over 60 minutes. Treat for 7–14 days. Normal renal function: 10mg/kg every 24hrs. Renal impairment: CrCl 30–50mL/min: 7.5mg/kg every 24 hrs; CrCl 10 – <30mL/min: 10mg/kg every 48hrs; CrCl<10mL/min or dialysis: not recommended.

Children:

<18yrs: not recommended.

Precaution(s):

Obtain (–) pregnancy test before treatment for women of childbearing potential; use appropriate effective contraception during treatment. Baseline CrCl≤50mL/min. Monitor renal function. Diabetes. CHF. Hypertension. Long QT syndrome, uncompensated heart failure, severe left ventricular hypertrophy: not recommended. Pregnancy (Cat.C): not recommended, may cause fetal harm. Nursing mothers.

Interaction(s):

Caution with other drugs that can cause QT prolongation. Increased risk of renal toxicity with NSAIDs, ACE inhibitors, loop diuretics). May interfere with coagulation tests (eg, PT/INR, aPPT, activated clotting time, coagulation-based factor Xa tests) and some urine protein tests.

Adverse Reaction(s):

Dysgeusia, GI upset, foamy urine; nephrotoxicity (reevaluate if occurs), infusion reactions ("red man syndrome"), superinfection (eg, antibiotic-associated colitis), QT prolongation.

How Supplied:

Single-use vials—10

Last Updated:

1/21/2010