The Food and Drug Administration (FDA) has approved Tyzeka (telbivudine) for the treatment of adults with chronic hepatitis B (HBV), a serious viral infection that attacks the liver and can cause lifelong infection, scarring of the liver (cirrhosis), and eventually liver cancer, liver failure, and death.
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 United States.
"In a typical year, an estimated 70,000 Americans become infected with chronic HBV, and some 5,000 of them will die of the complications caused by the disease," said Dr. Steven Galson, Director of the Center for Drug Evaluation and Research. "Tyzeka offers prescribers another option for treating these patients."
Tyzeka was studied in a year-long 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.
HBV is spread when blood from an infected person enters the body of a person who is not infected, sometimes by sexual contact or blood contamination. 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.