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FDA Oks Glaxo's Thrombocytopenia Drug Promacta For New Indication - Update

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11/19/2012 12:05 PM ET

The U.S. Food and Drug Administration on Monday approved GlaxoSmithKline plc's (GSK: Quote, GSK.L) Promacta as a new indication for treatment of thrombocytopenia -low blood platelet counts- in patients with chronic hepatitis C to allow them initiate and maintain interferon-based therapy.

The approval makes Promacta (eltrombopag) the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to low blood platelet counts. Promacta in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response.

Eltrombopag was discovered as a result of research collaboration between Glaxo and Ligand. It is a medication that has been developed for conditions that lead to thrombocytopenia (abnormally low platelet counts). Ligand stock is currently up 13 percent in afternoon trade, following the news of the FDA approval.

Eltrombopag is marketed under the brand names Promacta in the U.S. and Revolade in Europe and rest-of-World. The drug is approved in 90 countries as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, or ITP. In the U.S., Promacta is already indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

The additional approval for Promacta is based on results from two Phase III randomized, double-blind, placebo-controlled studies that collectively enrolled 1,521 patients with platelet counts of less than 75,000/µL.

The most common adverse reactions in trials in thrombocytopenic patients with chronic hepatitis C for Promacta versus placebo were anemia, pyrexia, fatigue, headache, nausea, diarrhea, myalgia, alopecia, peripheral edema, among others.

About 4.2 million people in the U.S. have chronic hepatitis C, the most common blood-borne virus. It is estimated that up to 3.5 percent of these patients have platelet counts of less than 75,000/µL, which could make them ineligible to start or maintain interferon-based therapy.

Ligand stock is trading at $18.74, up $2.07 or 12.44%, on a volume of 0.7 million shares on the Nasdaq.

GSK is trading at $42.55, up 1.36%, on a volume of 1 million shares on the NYSE. In London, the stock closed at 1,337 pence, up 0.87%, on a volume of 6.7 million shares.

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by RTT Staff Writer

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