FDA approves new
hepatitis drug

The tens of thousands of people in the United States who are infected by hepatitis B each year were given access to a new drug on Wednesday to fight the virus.

The Food and Drug Administration said it approved Tyzeka, known generically as telbivudine, for use in treating adults with chronic hepatitis B. The drug is not a cure but can suppress the hepatitis B virus and reduce the liver inflammation that accompanies the disease, the FDA said.

Hepatitis B is caused by a virus that infects the liver. It can cause scarring, cancer, and failure of the liver as well as death. There are now six FDA-approved drugs to treat hepatitis B.

Tyzeka was developed by Idenix Pharmaceuticals Inc. of Cambridge, Mass., and the Swiss drug company Novartis Pharma AG.

The Hepatitis B Foundation estimates that nearly 100,000 people in the United States are infected annually. Most recover from the infection, although some go on to develop chronic conditions. About 5,000 people in the United States die each year from hepatitis B and its complications.

The virus can be spread through infected blood, typically during unprotected sex, childbirth, or through the sharing or reuse of hypodermic needles.

Side effects of Tyzeka include elevated levels of an enzyme suggestive of the breakdown of muscle tissue, upper respiratory tract infection, fatigue, headache, abdominal pain, and cough, the FDA said.

Among other drugs in the same class, there have been reports of fatal cases in which patients suffered severe enlargement and accumulation of fat in the liver, the FDA said. (AP)