The U.S. Food and Drug Administration said Wednesday that it approved Novartis AG's (NVS) drug Tyzeka for the treatment of chronic hepatitis B.
The drug, a once-daily tablet, was developed by Idenix Pharmaceuticals Inc. (IDIX) with Novartis under a development and commercialization pact.
American depositary shares of Novartis, which is based in Switzerland, closed Wednesday at $60.74, up 42 cents, while shares of Cambridge, Mass.-based Idenix closed at $9.85, up 9 cents. In after-hours trading, Idenix rose 2% to $10.05 while Novartis was unchanged.
According to the FDA, a yearlong trial showed antiviral effectiveness of the drug, including the suppression of hepatitis B virus, and improvement in liver inflammation comparable to Epivir-HBV, one of five other medications approved to treat patients with the condition.
Novartis said in an email that in the phase III of the trial, 56% of all Tyzeka-treated patients achieved undetectable levels of the virus in the first 24 weeks of treatment. The virus remained undetectable at one year in 95% of those patients.
Chronic hepatitis B attacks the liver and can cause lifelong infection, scarring of the liver, and eventually liver cancer, liver failure and death.
The virus is spread when blood from an infected person enters the body of someone who isn't infected, sometimes by sexual contact or blood contamination.
An estimated 1.25 million Americans are currently infected with the virus, and 350 million people are infected worldwide. The disease is responsible for up to 1.2 million deaths each year, according to Novartis.
Side effects of the drug included upper respiratory tract infection, fatigue, headache, abdominal pain and cough, the FDA said.
In addition, after several weeks to months of Tyzeka use, some patients developed symptoms ranging from transient muscle pain to muscle weakness.
The agency also said that using Tyzeka hasn't been shown to reduce the risk of infecting others with hepatitis B.
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