title: The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.
abstract: On 11(th) 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 50×10(9)/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).
authors.affiliation: European Medicines Agency, London, UK. Maria.NietoGutierrez@ema.europa.eu
authors.forename: Maria
authors.initials: M
authors.lastname: Nieto
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Calvo
authors.forename: Ian
authors.initials: I
authors.lastname: Hudson
authors.forename: Peter
authors.initials: P
authors.lastname: Feldschreiber
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Ching Cheng
authors.initials: CC
authors.lastname: Lee
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Lay
authors.forename: Anna
authors.initials: A
authors.lastname: Valeri
authors.forename: Eric
authors.initials: E
authors.lastname: Abadie
authors.forename: Angela
authors.initials: A
authors.lastname: Thomas
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
mesh_terms: D000328:Adult; D000818:Animals; D001565:Benzoates / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D006834:Hydrazines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D011720:Pyrazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D001565:Benzoates; D006834:Hydrazines; D011720:Pyrazoles; C520809:eltrombopag