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Novartis drug for chronic hepatitis B gets FDA nod

Written by: Staff
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WASHINGTON, Oct 25 (Reuters) The US Food and Drug Administration said today it has approved Novartis AG's telbivudine once-a-day drug for treating adults with chronic hepatitis B, a viral infection that attacks the liver.

During clinical studies of the drug, also known as Tyzeka, it was generally well tolerated and most adverse events were mild to moderate, the FDA said in a statement.

Approximately 70,000 Americans are infected with chronic hepatitis B annually and 5,000 of them die from complications of the disease, according to the FDA. It is sometimes spread through sexual contact or blood contamination.

''Tyzeka offers prescribers another option for treating these patients,'' Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Common side-effects of Tyzeka included elevated levels of an enzyme that can lead to muscle weakness, upper respiratory tract infection, fatigue, headache, abdominal pain and cough, the FDA said.

Some patients who used the drug for several weeks to months experienced transient muscle pain to muscle weakness, but they saw improvements when they stopped using Tyzeka, according to the government agency.

Novartis in 2003 partnered with Idenix Pharmaceuticals and obtained a license for the company's telbivudine product candidates. Novartis also acquired a majority stake in Idenix.

The FDA also said that using Tyzeka has not been shown to reduce the risk of infecting others with hepatitis B through sexual contact or blood contamination.

Reuters DKS VP0230

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