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.
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 由加拿大温尼伯的Cangene Corp制造。 [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-04-18 10:18