The U.S. Food and Drug Administration announced on April 6th that it had approved the first biologic drug designed to prevent reinfection with the hepatitis B virus in previously exposed liver transplant patients.

HepaGam B, a first-of-its-kind immune globulin product manufactured by Cangene Corp. of Winnipeg, Canada, is made from a protein derived from human plasma that can provide immunity to the hepatitis B virus.

Patients who have received a transplant as a result of liver failure caused by hepatitis B 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 Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research.

The FDA said it 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

Patients must receive injections at the time of liver transplant and throughout their lives, the FDA added.

The FDA approved HepaGam B a year ago to prevent hepatitis B infection acquired through sexual or contact exposure, and in unborn infants whose mothers had been exposed to the virus.