Nabi moves toward licensure of hepatitis B antibody product

By Elaine Rigoli

Tampa, Fla., May 30 - Nabi Biopharmaceuticals announced that its Biologic License Application for Nabi-HB Intravenous will be reviewed and discussed by the Food and Drug Administration's Blood Products Advisory Committee at a meeting scheduled for July 13 in Gaithersburg, Md.

Nabi said this progress with regulators is a move toward the licensure of its antibody product to prevent re-infection with hepatitis B in liver transplant patients in the United States and Europe.

The Blood Products Advisory meeting represents the culmination of lengthy discussions between the FDA and Nabi Biopharmaceuticals concerning the data that might be accepted to support the BLA, the company said in a news release.

The Blood Products Advisory Committee is expected to render its view as to whether the BLA for Nabi-HB Intravenous for the prevention of recurrence of hepatitis B after liver transplant should be approved based on a combination of prospective and retrospective clinical data, the release said.

Nabi said such data should be sufficient for approval given Nabi-HB's widely accepted off-label use in liver transplant patients.

Currently, Nabi-HB is licensed in the United States to provide protection from infection after accidental exposure to the hepatitis B virus.

Based in Boca Raton, Fla., Nabi develops products that fight serious medical conditions.

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