Nabi: FDA committee recommends Nabi-HB intravenous to prevent hepatitis B

By Elaine Rigoli

Tampa, Fla., July 13 - Nabi Biopharmaceuticals said the Blood Products Advisory Committee of the Food and Drug Administration rendered a positive opinion of the company's Biologic License Application for Nabi-HB intravenous.

The committee voted to recommend approval of the use of Nabi-HB intravenous for the prevention of recurrence of hepatitis B after liver transplant.

The FDA generally follows the recommendations of its advisory committees, although it is not obligated to do so.

Nabi Biopharmaceuticals submitted its BLA for Nabi-HB in November 2002. Nabi-HB intravenous has received orphan-drug status in the United States.

If Nabi-HB is approved by the FDA, it would be the only product available in the United States indicated for the protection of the transplanted liver from HBV infection in HBV-positive liver transplant patients, the company said in a news release.

The U.S. Centers for Disease Control and Prevention estimates that there are 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 about 6,000 liver-transplant procedures are conducted each year in the United States, of which 200 to 250 are due to hepatitis B.

Nabi is a biopharmaceutical company based in Boca Raton, Fla.

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