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Data shows Glaxo drug similar to placebo-US FDA
www.forbes.com Company data for GlaxoSmithKline (nyse: GSK - news - people ) Plc's Promacta shows the experimental platelet-boosting drug works about as well as a placebo, a Food and Drug Administration reviewer said in documents released Wednesday.
Europe's biggest drugmaker is seeking U.S. approval for the drug as a short-term treatment for chronic idiopathic thrombocytopenia purpura (ITP), an autoimmune disease that reduces blood platelets crucial for blood clotting.
But the FDA reviewer, who was not named, said studies comparing Promacta, or eltrombopag, to a placebo pointed to some bleeding control but not enough to support the company's claims for treating the disease.
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