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Glaxosmithkline (GSK): FDA OKs New Indication For PROMACTA

 November 19, 2012 09:26 AM
 


(By Balachander) GlaxoSmithKline Plc (NYSE: GSK) said the U.S. health regulators have approved its new indication for PROMACTA to treat thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

"Today's FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge," the UK-based healthcare giant said. "This means more chronic hepatitis C patients may be able to start and stay on interferon-based therapy. That gives these patients a better chance to achieve a viral cure." 

According to GlaxoSmithKline, PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts.

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The U.S. Food and Drug Administration (FDA) approved PROMACTA based on two Phase III randomized, double-blind, placebo-controlled, multicenter studies.

PROMACTA (eltrombopag) was given accelerated approval by the U.S. FDA under the trade name Promacta in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen.

PROMACTA was discovered as a result of a research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals Inc. (NASDAQ: LGND).

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PROMACTA in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response (SVR) or viral cure, the company noted.

U.S.-listed shares of GSK ended at $41.98 on Friday.

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