Peginesatide is intended as a substitute for currently available erythropoiesis stimulating agents in the treatment of anaemia in chronic kidney disease (CKD) patients on dialysis. If licensed, peginesatide may offer another treatment option for this patient group. It is administered less frequently than most currently available treatments and can be stored at room temperature for up to three months once dispensed. Peginesatide is a synthetic peptide mimetic of human erythropoietin that binds directly to the erythropoietin receptor on red blood cell precursors to stimulate red cell formation.
The UK whole population prevalence of stage 3-5 CKD is 4.9%, with an estimated age-standardised prevalence of 8.5% (10.6% in females and 5.8% in males). The prevalence of anaemia in people with CKD depends on the stage of kidney disease, and ranges from 1% in people with moderate decreases in glomerular filtration rate to 33% in people with established renal failure. An estimated 90,000-108,000 of the population in England and Wales have anaemia associated with CKD.
Current treatment options for anaemia in CKD include blood transfusions (not indicated for people with anaemia of CKD in whom kidney transplant is a treatment option), the correction of iron or folate deficiency, epoetins, darbepoetin, and methoxy polyethylene glycol-epoetin beta. Peginesatide has completed phase III clinical trials comparing its effect on haemoglobin concentration against treatment with epoetin alfa or darbepoetin alpha.