FDA Approves Drug for Chronic Hepatitis B in Adults

New molecular entity safe and effective in large clinical trial

THURSDAY, Oct. 26 (HealthDay News) -- The U.S. Food and Drug Administration has approved Tyzeka (telbivudine) for the treatment of chronic hepatitis B virus (HBV) in adults. Manufactured by Novartis Pharma Stein AG in Stein, Switzerland, and marketed by Idenix Pharmaceuticals, Inc. in Cambridge, Mass., Tyzeka is a new molecular entity.

In a one-year trial of 1,367 patients with chronic HBV, patients taking Tyzeka showed suppression of the virus and improvement in liver inflammation that compared with Epivir-HBV (lamivudine). Tyzeka does not reduce risk of transmission of the disease.

Mild to moderate adverse effects included elevated creatinine phosphokinase, upper respiratory tract infection, fatigue, headache, abdominal pain and cough. Drugs in the same class have been linked to lactic acidosis and potentially fatal enlargement and accumulation of fat in the liver. Patients who wish to discontinue the drug must do so under the guidance of a physician as it could lead to a sudden and severe worsening of HBV.

"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 [and] Tyzeka offers prescribers another option for treating these patients," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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