The United States Food and Drug Administration today
announced its approval of HepaGam B for the prevention of hepatitis B
re-infection in certain liver transplant patients.
Liver transplant is intended to help those whose livers are severely
damaged by conditions including hepatitis B viral infection.
Hepatitis B virus (HBV) carriers are at risk
of re-infection of the virus when the liver is replaced.
HepaGam B is the first product of its kind (an immune globulin product) indicated
for this purpose.
In January 2006, FDA
already approved HepaGam B to prevent transmission of hepatitis B virus through
many other routes including exposure to infected blood or body fluids.
Hepatitis B is a serious infectious disease caused by a virus that damages
the liver, potentially leading to liver cancer, liver failure and death.
HepaGam B, also known as
Hepatitis B Immune Globulin (Human)
works by providing an
immediate immune response to
HBsAg, the infectious agent of the hepatitis B
virus. This immunity protects patients previously exposed to
HBV.
To have the protective effect against HBV, the drug needs to be injected at
the time of their liver transplant and throughout their lives.
The FDA approval is based on the manufacturer's clinical data from a study
of HBV-infected persons undergoing full liver transplants. The study showed the
virus recurrence rate was reduced from 86 percent to about 13 percent.
Adverse reactions were similar to other immune globulin products and included
headache and hypertension, the FDA says.
HepaGam B is manufactured by Cangene Corp. of
Winnipeg,
Canada.
