GSK initiates Ph III trial of Promacta

UK drug major GlaxoSmithKline has initiated the Phase III RAISE trial (RAndomized placebo-controlled Idiopathic thrombocytopenic purpura Study with Eltrombopag) of its novel oral platelet growth factor Promacta (eltrombopag) as a treatment for ITP. The study follows an earlier assessment of two doses of the drug which indicated that treatment allowed 70% and 81% of patients, respectively, to achieve blood platelet counts of greater than 50,000 per microliter, in comparison with 11% of those in the placebo group. Analysts at Lehman Brothers said that the US Food and Drug Administration has not yet confirmed if it will require the results of the RAISE trial to be included in the investigational thrombopoetin receptor agonist's New Drug Application, and therefore it could not say whether the NDA would be filed in 2007 or 2008.