GSK announces positive results of Revolade phase III trial

GlaxoSmithKline (GSK) has announced the results of a key phase III trial of Revolade (eltrombopag), with the study showing that administration of the compound in chronic idiopathic thrombocytopenia purpura (ITP) patients resulted in a significant increase in platelet counts and reduced bleeding.

The trial involved 114 patients who have already received traditional treatments for ITP but have not responded adequately, with these patients given a once-daily dose of eltrombopag at 50-75 mg.

Results presented at the congress of the European Haematology Association in Vienna showed that 16 per cent of patients treated with placebo achieved a platelet count exceeding 50,000 per microlitre, compared to 59 per cent of patients treated with eltrombopag.

Dr Drew Provan, senior lecturer in haematology at the department of haematology at Royal London Hospital, said: “ITP is a condition that can be serious for some individuals, or those who fail to respond to therapy and not only puts patients at risk of bleeding but may also cause severe fatigue, bruises and complications during surgery or pregnancy.”

He added that the results from this phase III clinical trial suggest that eltrombopag could provide a new treatment option for the reduction of bleeding episodes in these patients.

In June 2006, GSK announced the publication of phase II trial results of eltrombopag, reporting the data as “very exciting” and a “major scientific advance”.