Hepatitis B Drug Tyzeka Approved By FDA

by Malathi Raman on  October 26, 2006 at 12:36 PM Drug News   - G J E 4
Hepatitis B Drug Tyzeka Approved By FDA
On Wednesday, the US Food and Drug Administration gave its approval for Tyzeka (telbivudine) manufactured by Novartis Pharma to be used in the treatment of chronic Hepatitis B (HBV). Clinical studies have shown that the drug does not have serious side effects and is usually well tolerated.

Hepatitis B is a viral infection affecting the liver and infects about 70,000 Americans every year. It is a serious illness and around 5000 people die from complications like liver cancer, cirrhosis and hepatic failure. The new drug gives doctors another option for treatment.

A one year study of 1367 patients showed that telbivudine had a better response when compared to other drugs like lamivudine. Over a period of time however some participants developed muscle weakness and pain which stopped when the medication was discontinued. But the agency has warned against sudden discontination as symptoms could worsen.

Hepatitis B infection usually transmits through sexual contact or contaminated blood. Tyzeka does not reduce the risk of transmission, nor does it cure the disease. Common side-effects of Tyzeka are elevated levels of an enzyme causing muscle weakness, upper respiratory tract infection, fatigue, headache, abdominal pain and cough, the FDA said.

Source: Medindia

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