FDA APPROVES NOVARTIS' HEPATITIS B TREATMENT

The FDA has approved Novartis' Tyzeka (telbivudine) for the treatment of adults with chronic hepatitis B virus (HBV) infection. Tyzeka is a new molecular entity, which is a term used by the FDA to describe a medication containing an active substance that has never before been approved for marketing in any form in the U.S.

Tyzeka was studied in a one-year international clinical trial in 1,367 patients with chronic HBV. Three-quarters of the trial participants were male, and all were 16 years of age or older. The trial produced evidence of antiviral effectiveness, including the suppression of hepatitis B virus and improvement in liver inflammation comparable to Epivir-HBV (lamivudine), one of five other medications approved to treat patients with chronic HBV.

Tyzeka is not a cure for hepatitis B, and long-term treatment benefits of this drug are not known. Use of Tyzeka has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. In clinical studies Tyzeka was generally well-tolerated, and most reported adverse events were mild to moderate.