FDA clears Cangene's HepaGam B for HBV

The US Food and Drug Administration has approved Canadian drugmaker Cangene's HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. This is the first immunoglobulin product cleared for this indication.

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, director of the 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," he said.