NPLATE (romiplostim), 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 adults with 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.
Clinical Added Value
Évaluation des médicaments