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EMA approves Revolade to be used in adults with long-term immune thrombocytopenic purpura (ITP)

Revolade is medicine that contains the active substance eltrombopag. It is available as round tablets (white: 25 mg; brown: 50 mg).

Revolade is used in adults with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys the platelets (components in the blood that help it to clot). Patients with ITP have low platelet counts and are at risk of bleeding.

Revolade is used in patients who have had their spleen removed and who do not respond to treatment with medicines such as corticosteroids or immunoglobulins. It can also be considered for use in patients who have previously been treated for ITP who cannot have surgery to remove their spleen. The spleen is an organ that is involved in the destruction of platelets.

Because the number of patients with ITP is low, the disease is considered ‘rare’, and Revolade was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 August 2007.
The medicine can only be obtained with a prescription.

Treatment with Revolade should be supervised by a doctor who has experience in treating blood diseases.

The recommended starting dose is 50 mg once a day, except in patients of East Asian descent (such as Japanese, Chinese, Taiwanese or Korean) where it should be 25 mg once a day. After treatment has started, the dose should be adjusted for each patient with the aim of keeping the level of platelets high enough to prevent bleeding (above 50,000 platelets per microlitre). The daily dose should not exceed 75 mg. Patients should not take any antacids, dairy products or mineral supplements for four hours before or four hours after taking Revolade. For more information, see the Summary of Product Characteristics (also part of the EPAR).

The active substance in Revolade, eltrombopag, stimulates the production of platelets. In the body, a hormone called ‘thrombopoietin’ stimulates the production of platelets by attaching to certain receptors in the bone marrow. Eltrombopag attaches to and stimulates the same receptors as thrombopoietin. This leads to an increased production of platelets.

The effects of Revolade were first tested in experimental models before being studied in humans.

Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 adults with chronic ITP. The patients had previously been treated but the treatments had not worked or the disease had come back. All of the patients had a platelet count of less than 30,000 per microlitre at the start of the studies. In the first study, the main measure of effectiveness was the number of patients whose platelet count had increased to at least 50,000 cells per microlitre after six weeks. In the second study, it was the number of patients who had a platelet count between 50,000 and 400,000 per microlitre during six months of treatment.

Revolade was more effective than placebo at treating patients with chronic ITP. In the first study, 59% of the patients who took Revolade (43 out of 73) had a platelet count of at least 50,000 per microlitre after six weeks, compared with 16% of those who took placebo (6 out of 37). In the second study, patients taking Revolade were around eight times more likely than those taking placebo to reach a platelet count of between 50,000 and 400,000 per microlitre during the six months of treatment.

The most common side effect with Revolade (seen in more than 1 patient in 10) is headache. There is also a risk of liver problems and thromboembolic complications (problems with clots in blood vessels). Bleeding can also come back after the medicine is stopped For the full list of all side effects reported with Revolade, see the Package Leaflet.

Revolade should not be used in people who may be hypersensitive (allergic) to active substance or any of the other ingredients. The medicine should be used with caution in patients who have moderate or severe liver problems. For more information, see the Summary of Product Characteristics.

The Committee for Medicinal Products for Human Use (CHMP) decided that Revolade’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The company that makes Revolade will ensure that doctors in all Member States who will prescribe the medicine are provided with educational materials reminding them how the medicine should be used and of the medicine’s possible side effects such as liver problems, thromboembolic complications and the recurrence of bleeding.

The European Commission granted a marketing authorisation valid throughout the European Union for Revolade to GlaxoSmithKline Trading Services Limited on 11 March 2010. The marketing authorisation is valid for five years, after which it can be renewed.

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Source :

European Medicine Agency

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