REVOLADE (eltrombopag), thrombopoietin receptor agonists
HAEMATOLOGY - New indication
Opinions on drugs - Posted on Jun 28 2017
Reason for request
Extension of indication
Minor improvement in chronic autoimmune thrombocytopaenic purpura when usual treatments have failed, in non-splenectomised adultswith no contraindication to surgery
- Prior to the extension of the Marketing Authorisation of NPLATE and REVOLADE in non-splenectomised adults with no contraindication to surgery, these medicinal products were a treatment for chronic (idiopathic) autoimmune thrombocytopaenic purpura (ITP) in adults where the usual treatments have failed in refractory splenectomised patients and in non-splenectomised adults in case of contraindication to surgery.
- Now their use in pre-splenectomy has been validated by Marketing Authorisation. However, they must be used with caution given the uncertainties about long-term safety, as well as in non-splenectomised patients.
Moderate improvement in chronic autoimmune thrombocytopenic purpura where usual treatments have failed in children > 1 year
- REVOLADE now has Marketing Authorisation in the treatment of chronic (idiopathic) autoimmune thrombocytopenic purpura (ITP) that is refractory to other treatments in children > 1 year.
- A galenic presentation in the form of a powder for oral suspension allows adapted administration, especially in children < 6 years.
- In children > 1 year, the efficacy data are very short-term, but in this population the medical need is substantial.
Clinical Added Value
Évaluation des médicaments