Drug maker GlaxoSmithKline plc (GSK) Saturday announced positive safety and efficacy results from Randomized placebo- controlled ITP Study with Eltrombopag or Promacta. The study indicates that patients who received Promacta over six months were eight times more likely than placebo to generate sustained elevated platelet counts than patients who received placebo.
Promacta or Eltrombopag is an oral non-peptide thrombopoietin receptor agonist for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Promacta was discovered as a result of research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals (LGND).
Chronic ITP is a disorder marked by increased platelet destruction and or inadequate platelet production in the blood, which causes an increased risk of bleeding.
The six-month, double-blind, placebo-controlled, Phase III study also indicates that patients receiving Promacta experienced decreased bleeding symptoms and a reduced need for concomitant and rescue ITP medications.
The study enrolled 197 patients and, of these, approximately 50% had platelet counts less than or equal to 15,000/microliters.
The data presented at the American Society of Hematology also noted that the overall incidence of adverse events was similar between the Promacta (87%) and placebo groups (92%), which were mostly mild to moderate in severity. Headache was the most common adverse event in both groups (greater than or equal to 30%).
Promacta received accelerated approval from the FDA on November 20 as a thrombopoietin receptor treatment for patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
GSK plans to submit a Marketing Authorization Application (MAA) for eltrombopag in Europe in 2008.
GSK closed Friday's regular trading at $35.81, up $1.71 or 5.01% on a volume of 3.06 million shares.
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