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SMC recommends GSK's Revolade for ITP

The Scottish Medicines Consortium has recommended GSK's Revolade for patients in Scotland with chronic immune thrombocytopenic purpura (ITP)
The Scottish Medicines Consortium (SMC) has recommended GlaxoSmithKline's (GSK) Revolade (eltrombopag) for chronic immune thrombocytopenic purpura (ITP) for restricted use in NHS Scotland. Scotland is the first place in the UK to have taken this step.

The recommendation states that eltrombopag treatment should remain under the supervision of a physician experienced in the treatment of haematological diseases. It is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments such as corticosteroids and immunoglobulins. It may be considered as a second-line treatment for adult non-splenectomised patients where surgery is contraindicated. In both populations, it is restricted to use in those with severe symptomatic ITP or a high risk of bleeding.

Eltrombopag has been shown to be significantly more effective than placebo in raising and maintaining platelet counts at (or above) a minimum target level in previously treated patients with ITP.

Eltrombopag is the first oral thrombopoietin receptor agonist (TRA) licensed for this patient population. It has an innovative mode of action, which increases platelet production, which is a different therapeutic approach to traditional ITP treatments, which reduce platelet destruction.

Dr Mark Drummond, consultant haematologist and honorary senior clinical lecturer, Gartnavel General Hospital, commented: "This is fantastic news for patients in Scotland and we are delighted with the decision from the SMC. Eltrombopag is an innovative treatment option which represents a big step forward in the management of ITP. It is relatively easy to take and offers a reduced risk of bleeding during treatment, something that we know worries patients and has an impact on their quality of life."

Chronic ITP is a serious condition, where patients have low platelet levels either because the body does not produce enough platelets or destroys too many. Platelets are essential to normal clotting, so patients with ITP are at increased risk of bleeding and may develop bruises, experience nose or gum bleeds and other types of bleeding that are difficult to stop. 

Eltrombopag received marketing authorisation in Europe in March 2010 based on results from two phase III, randomised, double-blind, placebo-controlled clinical trials and two open-label studies involving previously-treated adult patients with chronic ITP. These studies showed that patients treated with eltrombopag experienced significant increases in platelet counts and a reduction in the incidence of bleeding, compared with those taking placebo. Treatment with eltrombopag also allowed patients to reduce the dose of their concomitant medications, such as steroids. 

11th August 2010

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