The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to GlaxoSmithKline (GSK) for Revolade (Eltrombopag). The drug is aimed for the oral treatment of thrombocytopenia in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Reportedly, CHMP has recommended the marketing authorisation of Eltrombopag in the EU 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.
Paolo Paoletti, SVP and global head of oncology research and development at GSK, said: “Eltrombopag is a 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. Eltrombopag is another example of our continued investment in R&D and our long-term commitment to improving the lives of patients.”