Technology | February 26, 2007

Chronic HBV Treatment Contains Active Substance New to U.S.

Tyzeka (telbivudine) has just been FDA cleared to treat adults with chronic hepatitis B (HBV), a viral infection that attacks the liver and can cause lifelong infection, scarring of the liver and eventually liver cancer, liver failure and death. Tyzeka is a new molecular entity, which is a term used by the FDA to dexcribe 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 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 trail produced evidence of anitviral 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.

In clinical studies Tyzeka was generally well tolerated, and most reported adverse events were mild to moderate. The most common side effects were elevated CPK (creatinine phosphokinase, an enzyme that is present in muscle tissue and is a marker for breakdown of muscle tissue), upper respiratory tract infection, fatigue, headache, abdominal pain and cough.

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