DOW JONES NEWSWIRES GlaxoSmithKline PLC (GSK) said Saturday that a recent long-term study of its new drug to treat a blood condition showed positive results.
The Food and Drug Administration last month granted accelerated approval to the drug, Promacta. The FDA's oncologic drugs advisory committee had said clinical studies demonstrated a favorable risk-benefit profile for its use in short-term treatment of chronic immune thrombocytopenic purpura, or ITP, which involves low platelet counts and spontaneous bleeding.
GlaxoSmithKline said a Phase III randomized placebo-controlled ITP study with eltrombopag, or RAISE, showed that patients receiving Promacta were eight times more likely than those on a placebo to maintain elevated platelet counts.
Also, patients receiving Promacta had fewer bleeding symptoms and a reduced need for other medications.
Results of the study will be presented Monday morning at the American Society of Hematology meeting in San Francisco.
"Promacta is the first approved agent to show that generating platelets can be achieved and maintained with an oral therapy," said Dr. Paolo Paoletti, senior vice president of oncology R&D at GlaxoSmithKline.
-By Kathy Shwiff, Dow Jones Newswires; 201-938-5975; Kathy.Shwiff@dowjones.com
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(END) Dow Jones Newswires
December 06, 2008 11:15 ET (16:15 GMT)

Publié le 06 Décembre 2008 Copyright © 2008 Dowjones