The FDA generally follows the recommendations of its advisory committees, although it is not obligated to do so. Nabi Biopharmaceuticals submitted its biologic license application (BLA) for Nabi-HB intravenous in November 2002. The drug has also received orphan status in the US.
If Nabi- HB Intravenous is ultimately approved by the FDA, it would be the only product available in the US indicated for the protection of the transplanted liver from HBV infection in HBV-positive liver transplant patients.
The US Centers for Disease Control (CDC) currently estimates that in the US there are approximately 1.2 million chronic hepatitis B carriers, 8,500 new hepatitis B infections per year, and 5,000 individuals who die annually from hepatitis B or its complications. A total of approximately 6,000 liver transplant procedures are conducted each year in the US, of which 200 to 250 are due to hepatitis B.
Nabi-HB, a non-intravenous form of the product, is currently licensed in the US to provide protection from infection after accidental exposure to the hepatitis B virus. It is also used off-label in liver transplant patients at risk for re-infection and is acknowledged as the standard-of-care.
“While Nabi-HB is used extensively off-label to protect liver transplant patients from HBV re-infection, patients would benefit greatly from a standardization for the product’s use. FDA approval for Nabi- HB Intravenous, if granted, would provide physicians with the information they need to provide their patients with the most beneficial treatment and dosing regimens both at the time of transplant and for long-term maintenance,” said Dr David Imagawa, professor of clinical surgery, hepatobiliary and pancreas surgery, University of California.