GSK's eltrombopag performs well in ITP

UK drug major GlaxoSmithKline says that the results from a study of eltrombopag, its developmental oral platelet growth factor, show that the drug stimulated a significant increase in platelet count compared with placebo, in poorly responding idiopathic thrombocytopenic purpura patients, including those with very low counts or who had undergone a prior splenectomy.

The data, which were presented at the recent European Hematology Association congress, held in Amsterdam, the Netherlands, are from a global Phase II assessment of the drug that enrolled 118 patients with chronic ITP. Participants, who were permitted to continue receiving maintenance immunosuppressive therapy throughout the program's six-week duration, were randomized to receive one of three doses of the drug (30mg, 50mg or 75mg) or placebo.

The results showed that 70% of those patients receiving the 50mg dose, and 81% of those treated with the 75mg dosage, achieved the primary endpoint of a platelet count greater than 50,000/microL, compared with 11% of those given placebo. The firm added that, overall, a dose dependent increase in the proportion of responders was observed, with 28% of subjects on the 30mg dose also reaching the primary endpoint. In addition, the number of patients who experienced adverse events was comparable across all cohorts: placebo (59%); 30mg (47%); 50mg (47%); and 75mg (61%).