FDA OKs new hepatitis B drug

NEWS IN BRIEF — Posted Nov. 13, 2006

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A new molecular entity, telbivudine, or Tyzeka, was approved Oct. 25 by the Food and Drug Administration for the treatment of adults with chronic hepatitis B.

The new drug was studied in a year-long international clinical trial in 1,367 patients with chronic HBV. The results provided evidence of antiviral effectiveness that included suppression of the hepatitis B virus, the FDA reported. Results also showed improvement in liver inflammation comparable with lamivudine, one of five other drugs approved to treat patients with the disease.

In a typical year, an estimated 70,000 Americans become infected with chronic HBV, and about 5,000 will die from related complications, said Steven Galson, MD, MPH, director of the FDA's Center for Drug Evaluation and Research, in a statement.

The most common side effects of the new drug were elevated creatinine phosphokinase, upper respiratory tract infection, fatigue, headache, abdominal pain and cough.

Tyzeka is manufactured by Novartis Pharmaceuticals.

Note: This item originally appeared at

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