EPREX (epoetin alfa), erythropoiesis-stimulating agent
HAEMATOLOGY - New indication
Opinions on drugs - Posted on May 25 2018
Reason for request
Extension of indication
Substantial actual benefit in the treatment of anaemia in adults with myelodysplastic syndrome, but no clinical benefit demonstrated in the treatment of this syndrome.
- EPREX has Marketing Authorisation in the treatment of symptomatic anaemia in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin.
- Its efficacy has been demonstrated versus placebo in terms of erythroid response in a selected population requiring little or no transfusion. However, its superiority compared with placebo has not been established on return to normal haemoglobin values, reduction of transfusion requirements or improvement in quality of life.
- Like other EPOs, epoetin alfa can expose patients to rare but serious adverse effects: arterial thrombosis, severe skin toxicity and erythroblastopenia, in particular.
Improvement in actual benefit
Évaluation des médicaments