23. December 2009 12:25
The CHMP has issued a positive opinion for GSK’s Revolade (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
The CHMP has recommended the marketing authorisation of eltrombopag in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, such as corticosteroids and immunoglobulins therapies.
Eltrombopag may also be considered as a second-line treatment for adult patients where surgery to remove their spleen is contraindicated.
“Eltrombopag is an innovative treatment for thrombocytopenia in patients with chronic ITP. This once-a-day tablet is able to stimulate platelet production and reduce the risk of bleeding in a difficult-to-treat disease,” said Paolo Paoletti, SVP and Global Head of Oncology Research and Development, GSK. “Eltrombopag is another example of our continued investment in R&D and our long-term commitment to improving the lives of patients.”
ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.
Eltrombopag is the first oral platelet generator. It stimulates the proliferation and differentiation of megakaryoctes, resulting in an increase in platelet counts.
The positive opinion from CHMP was based on two Phase 3 clinical trials and two open-label studies in adults who have previously received treatment for chronic ITP. The studies showed that the patients treated with eltrombopag (plus the standard of care) experienced significant increases in platelet counts, a reduction in the incidence of bleeding and an improvement in quality of life, compared with those receiving placebo (plus the standard of care).
Orphan designation was granted by the European Commission for eltrombopag for the treatment of ITP on 3 August 2007.