FDA Approves Biologic to Prevent Hepatitis B Reinfection After Liver Transplant

The FDA has announced the approval of Cangene's HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the first immune globulin product approved for this purpose, the FDA said.

"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," Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said.

HepaGam B works by providing an immediate immune response to the virus. This immunity protects patients previously exposed to hepatitis B. Patients must receive injections at the time of their liver transplants 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 a study that showed a reduction in the virus recurrence rate in patients undergoing full liver transplants from 86 percent to roughly 13 percent. Adverse reactions were similar to those with other immune globulin products for other indications and included headache and hypertension.

HepaGam B is already approved to prevent hepatits B infection after acute exposure to blood or certain body fluids, perinatal exposure of infants to previously exposed mothers, sexual exposure and household exposure to people with acute hepatitis B infection.