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EMA marketing authorisation for Revolade

Marketing authorisation has been granted for GlaxoSmithKline (GSK)'s Revolade (eltrombopag) in all 27 member states of the EU

The European Medicines Agency (EMA) has granted marketing authorisation for GlaxoSmithKline (GSK)'s Revolade (eltrombopag), a once-daily oral treatment for adults with chronic immune thrombocytopenic purpura (ITP) - a blood disorder characterised by a low platelet count and excessive bleeding - in all 27 member states of the European Union. 

The authorisation for Revolade was granted based on the results from two phase III, randomised, double-blind, placebo-controlled clinical trials and two open-label studies in previously-treated adult chronic ITP patients. These studies showed that patients treated with Revolade (plus the standard of care) experienced significant increases in platelet counts and a reduction in the incidence of bleeding, compared to those taking placebo (plus the standard of care). Revolade treatment also allowed patients to reduce the dose of their concomitant medications, such as steroids.

Belonging to a class of agents known as thrombopoietin receptor agonists (TRAs), Revolade has a unique mode of action, which increases platelet production. This is a different therapeutic approach to existing ITP treatments such as immunoglobulins and corticosteroids, which reduce platelet destruction. 

Patients who have already had their spleen removed (splenectomy) and are not responding to other treatments such as corticosteroids and immunoglobulins are eligible to use Revolade, and it can also be considered as second-line treatment for adult non-splenectomised patients where surgery is contraindicated.

In the UK, the crude incidence of adult ITP is 3.9 per 100,000 persons per year. Quality of life is adversely affected in patients with chronic ITP, with a fear of bleeding considerably limiting patients' daily activities, such as participating in sports or manual work. Fatigue and depression are also often associated with ITP. 

According to Dr Drew Provan, senior lecturer in haematology, Barts and The London of School of Medicine and Dentistry: "Eltrombopag is an effective drug, which is easy to take, offering a reduced risk of bleeding during treatment as well as broadening the options available to chronic ITP patients."

15th March 2010


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