FDA Approves New Drug

    The Food and Drug Administration (FDA) today approved Tyzeka
    (telbivudine) for the treatment of adults with chronic hepatitis B (HBV), a
    serious viral infection that attacks the liver and can cause lifelong infection,
    scarring of the liver (cirrhosis), and eventually liver cancer, liver failure,
    and death. Tyzeka is a new molecular entity, which is a term used by the FDA to
    describe a medication containing an active substance that has never before been
    approved for marketing in any form in the United States.

    “In a typical year, an estimated 70,000 Americans become infected with
    chronic HBV, and some 5,000 of them will die of the complications caused by the
    disease,” said Dr. Steven Galson, Director of the Center for Drug Evaluation and
    Research. “Tyzeka offers prescribers another option for treating these
    patients.”

    Tyzeka was studied in a year-long international clinical trial in 1,367
    patients with chronic HBV. Three-quarters of the trial participants were male,
    and all were 16 years of age or older. The trial produced evidence of antiviral
    effectiveness, including the suppression of hepatitis B virus, and improvement
    in liver inflammation comparable to Epivir-HBV (lamivudine), one of five other
    medications approved to treat patients with chronic HBV.

    HBV is spread when blood from an infected person enters the body of a
    person who is not infected, sometimes by sexual contact or blood contamination.
    Tyzeka is not a cure for hepatitis B, and long-term treatment benefits of this
    drug are not known. Use of Tyzeka has not been shown to reduce the risk of
    transmission of HBV to others through sexual contact or blood
    contamination.

    In
    clinical studies Tyzeka was generally well tolerated, and most reported adverse
    events were mild to moderate. The most common side effects were elevated CPK
    (creatinine phosphokinase, an enzyme that is present in muscle tissue and is a
    marker for breakdown of muscle tissue), upper respiratory tract infection,
    fatigue, headache, abdominal pain and cough.

    Also, after several weeks to months of Tyzeka use, some patients
    developed symptoms ranging from transient muscle pain to muscle weakness. Those
    who developed muscle weakness experienced significant improvement in their
    symptoms when Tyzeka was discontinued.

    Patients should only stop Tyzeka after a careful discussion with their
    doctor. As has happened with other forms of treatment for hepatitis B, some
    patients who discontinued Tyzeka experienced a sudden and severe worsening of
    their hepatitis B. Therefore, patients who discontinue Tyzeka should be closely
    monitored by their doctor for at least several months.

    Among drugs in the same class as Tyzeka, some cases of lactic acidosis
    (too much acid in the body due to buildup of lactic acid) and severe enlargement
    and accumulation of fat in the liver, including fatal cases, have been
    reported.

    Tyzeka is manufactured by Novartis Pharma
    Stein AG, Stein, Switzerland and marketed and distributed by Idenix
    Pharmaceuticals, Inc., Cambridge, MA.

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