百时美施证明从乙肝病毒再感染肝移植术后“ZEUS”的研究与

StephenW

Biotest proves effective protection from Hepatitis B virus reinfection after liver transplantation in "ZEUS" study with subcutaneous hepatitis B immunoglobulin Zutectra®

    Category: Antibodies   
    Published on Thursday, 23 April 2015 11:07
    Hits: 109



    The Zutectra-Early-Use-Study (ZEUS) demonstrates safe and effective switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra®, at the earliest one week after liver transplantation
    No Hepatitis B virus reinfection after six months of Zutectra® prophylaxis with excellent safety and tolerability data
    Data presented at the 50th International Liver Congress 2015 in Vienna, Austria
    Zutectra® dossier submitted to European Medicines Agency (EMA) for EU-Approval

DREIEICH, Germany I April 23, 2015 I Biotest presents today the efficacy and safety results from the Zutectra-Early-Use-Study (ZEUS) at the 50th International Liver Congress 2015 in Vienna, Austria.

The international clinical phase III study was performed in 17 transplant centers in four of the Big-Five EU-Markets, Italy, Spain, France and United Kingdom. Zutectra® was administered subcutaneously combined with hepatitis B Virus virostatic therapy '8 – 18' days after transplantation preventing hepatitis B Virus (HBV) re-infection in patients at risk for hepatitis B virus recurrence.

47 adult patients suffering from life-threatening terminal liver disease due to long-lasting chronic hepatitis B or HCC (hepatocellular carcinoma) completed the study. There were no treatment failures and no clinical signs of a hepatitis B virus reinfection were observed. There were no treatment related serious-adverse-events (SAE) and only one treatment related but non-serious adverse-event (AE), a mild and transient hematoma at the injection site.

With the Zutectra-Early-Use-Study Biotest successfully extends the medical application of Zutectra® to allow the earliest conversion to subcutaneous administration. This contributes concomitantly to a safe, more time efficient, less costly patient care and better convenience for the patient.

Biotest submitted the dossier for "Zutectra-early-use" after liver transplantation to the EMA for EU-approval. The approval process is expected to be finalized in Q4 2015.

About Zutectra®:
Zutectra® was specifically developed by Biotest for the long-term treatment of patients after liver transplantation. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients to self-medication. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option.

The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra® in 2009. Zutectra® is currently marketed in the EU member states and major ROW markets.  

StephenW

百时美施证明从乙肝病毒再感染肝移植术后“ZEUS”的研究与皮下乙肝免疫球蛋白Zutectra®有效保护

    分类：抗体
    周四公布，2015年4月23日11:07
    点击数：109



    该Zutectra-早期使用-研究（ZEUS）表明高剂量静脉注射乙肝免疫球蛋白（HBIG），肝移植术后安全，有效切换到皮下HBIG，Zutectra®，最早1周
    没有Zutectra®经过半年多的乙肝病毒再感染预防与出色的安全性和耐受性数据
    数据发表在第50届国际肝病会议2015年在奥地利维也纳
    欧盟批准提交给欧洲药品管理局（EMA）Zutectra®档案

DREIEICH，德国我2015年4月23日我百时美施今天介绍来自奥地利维也纳的Zutectra，早期使用-研究（ZEUS）在第50届国际肝病会议2015年有效性和安全性结果。

在17个移植中心进行四个大五欧盟市场，意大利，西班牙，法国和英国的国际III期临床研究。 Zutectra®皮下注射结合乙肝病毒virostatic疗法“8 - 18'移植预防乙型肝炎病毒（HBV）再感染风险的患者乙肝病毒复发天后。

由于长期持久的慢性乙型肝炎或肝癌（肝细胞癌）47成人患者从危及生命的终端患有肝病的患者完成了研究。没有与治疗失败和乙型肝炎病毒的再感染的任何临床体征进行观察。没有与治疗相关的严重到不良事件（SAE）及仅一个治疗相关的，但非严重不良事件（AE），温和的和短暂的血肿在注射部位。

随着Zutectra，早使用，研究生物实验成功地扩展了Zutectra®的医疗应用程序，允许最早转化为皮下给药。这伴随有利于安全，更有效的时间，成本更低的病人护理和更好方便患者。

百时美施肝移植术后提交的卷宗“Zutectra早期使用”的EMA欧盟批准。预计审批过程在2015年第四季度完成。

关于Zutectra®：
Zutectra®是专门由百时美施用于长期治疗的患者肝脏移植后开发的。它是全世界在预灌封注射器用于皮下施用所述第一准备使用的B型肝炎免疫球蛋白的方法，而且使患者自我药疗。这提供了主治医生和患者一个不太痛苦，节省时间和简单的治疗选择。

欧盟委员会已批准上市批准百时美施用于乙肝免疫球蛋白Zutectra®2009年Zutectra®目前在欧盟成员国和主要ROW市场销售。