Tyzeka Approved to Treat Chronic Hepatitis B

WEDNESDAY, Oct. 25 (HealthDay News) -- The Novartis Pharma drug Tyzeka (telbivudine) was approved Wednesday by the U.S. Food and Drug Administration to treat chronic hepatitis B (HBV), a serious liver infection. The drug contains a new molecular entity that hadn't been previously approved for marketing in the United States, the FDA said.

Some 70,000 Americans are infected with HBV each year. It can cause scarring of the liver (cirrhosis), possibly leading to liver cancer, liver failure, and death. In a year-long trial of Tyzeka involving 1,367 patients, the drug outperformed lamivudine, one of five other medications approved to treat chronic HBV, the agency said.

HBV is typically spread via sexual contact or contaminated blood. Tyzeka is not a cure for the disease, nor has it been shown to reduce the risk of transmission, the FDA said. The long-term benefits of treatment with Tyzeka aren't known, the agency added.

After several weeks of use, some clinical trial participants developed muscle problems ranging from weakness to pain. Symptoms in many of these patients improved once the drug was discontinued.

But the agency warned that no one should stop using Tyzeka without consulting a doctor, since some people who discontinued the drug had a sudden and severe worsening of hepatitis B symptoms.