AbstractOn 11th March 2010, the European Commission issued a marketing authorization valid throughout the European Union for Revolade for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura. Revolade is an orphan medicinal product indicated for splenectomized patients with immune (idiopathic) thrombocytopenic purpura who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) and as second-line treatment for non-splenectomized patients where surgery is contraindicated. The active substance of Revolade is eltrombopag (ATC code B02BX05). Eltrombopag increases platelet production through activation of the thrombopoietin receptor. The recommended oral dose is 50 mg once daily to achieve and maintain a platelet count of the 50×109/L or more necessary to reduce or prevent the risk of bleeding. The benefit of Revolade is a durable response in maintaining platelet levels. The most common side effects include headache, nausea, hepatobiliary toxicity, diarrhea, fatigue, paresthesia, constipation, rash, pruritus, cataract, arthralgia and myalgia. The decision to grant the marketing authorization was based on the favorable recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency. The objective of this paper is to describe the data submitted to the European Medicines Agency and to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (www.ema.europa.eu).
- Received June 8, 2011.
- Accepted June 17, 2011.
- Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol. 2003; 120(4):574-96. Google Scholar
- Nplate (romiplostim). [Internet]. The European Medicines Agency: London; 2009. Google Scholar
- Revolade (eltrombopag). [Internet]. The European Medicines Agency: London; 2009. Google Scholar
- Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007; 357(22):2237-47. Google Scholar
- Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009; 373(9664):641-8. Google Scholar
- Cheng G, Saleh MN, Bussel JB, Marcher C, Vasey S, Mayer B. Oral eltrombopag for the long-term treatment of patients with chronic idiopathic thrombocytopenic purpura: results of a Phase III, double-blind, placebo-controlled study (RAISE). ASH Annual Meeting. 2008. Google Scholar
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Vol. 96 No. 9 (2011): September, 2011 : Online Only Articles
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