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【drug-news】FDA批准首个用于预防肝移植患者乙型
FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients
The U.S. Food and Drug Administration (FDA) today announced the approval of HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the first product of its kind (an immune globulin product) approved for this purpose.
Hepatitis B is a serious disease caused by a virus that attacks the liver and can cause lifelong infection, liver cancer, liver failure and death. Liver transplant patients who have already been exposed to the hepatitis B virus (HBV) are at an increased risk of reinfection because they have weakened immune systems.
"This approval provides a new treatment option for the reduction of hepatitis B recurrence in liver transplant patients with a prior history of this serious disease," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "It is the first immune globulin product--one of several classes of proteins derived from human plasma--approved for this use."
HepaGam B works by providing an immediate immune response to the virus. This immunity protects patients previously exposed to HBV. Patients must receive injections at the time of their liver transplant and throughout their lives. This product is manufactured from human plasma collected at U.S. licensed plasma centers from healthy donors.
FDA based its approval on the company's clinical data in a study of HBV-infected persons undergoing full liver transplants, which showed a reduction in the virus recurrence rate from 86 percent to about 13 percent. Adverse reactions were similar to other immune globulin products for other indications and included headache and hypertension.
In January 2006, FDA licensed HepaGam B to prevent infection with HBV for the following other purposes: after acute exposure to blood or certain body fluids containing HBV; perinatal exposure of infants to mothers previously exposed to HBV; sexual exposure to persons previously exposed to HBV; and household exposure to persons with acute HBV infection.
HepaGam B is manufactured by Cangene Corp. of Winnipeg, Canada.
FDA批准首个用于预防肝移植患者乙型肝炎再感染的生物制品
美国食品药品监督管理局今天宣布批准HepaGam B用于预防肝移植患者乙型肝炎再感染。HepaGam B是该类（一种免疫球蛋白产品）中首个获批用于该用途的产品。乙型肝炎是由病毒攻击肝脏引起的一种严重的疾病，能导致终身感染、肝癌、肝功能衰竭和死亡。因为免疫系统变弱，曾感染乙肝病毒的肝移植患者再感染的风险增加。
“该项批准向有乙型肝炎感染史的肝移植患者提供了一个新的降低乙肝复发的治疗选择。” FDA生物制品评价研究中心主任Jesse Goodman（医学博士，公共卫生硕士）说，“它是首个免疫球蛋白产品（从人血浆中分离得到的蛋白中的一种）被批准用于该用途”。
HepaGam B的作用机制通过对病毒直接产生免疫响应。其免疫性保护曾感染该乙肝病毒的患者。患者必须在肝移植时注射并遍及其肝脏。该产品用美国批准的血浆中心采集的健康捐献者的血浆制造。
FDA的批准基于该公司对于乙肝患者全肝移植的临床研究资料，该资料显示，病毒复发的比率由86%下降到13%。不良反应与用于其他适应症的免疫球蛋白产品类似，包括头痛和高血压。
2006年1月，FDA曾批准HepaGam B用于以下用途的乙肝病毒感染预防：含有乙肝病毒的血液或体液的急性暴露；曾感染乙肝母体的婴儿围产期暴露；感染乙肝者的性暴露；急性乙肝患者的家庭接触。
HepaGam B 由加拿大温尼伯的Cangene Corp制造。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-04-18 10:18
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