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New data has been presented by Hospira, showing Retacrit (epoetin zeta) to be as effective in achieving and maintaining haemoglobin (Hb) levels in end-stage renal failure patients with diabetic nephropathy, as epoetin alfa (Erypo).
Hospira, the world leader in generic injectable pharmaceuticals, found the results after carrying out two pivotal phase III studies with Retacrit – a biosimilar erythropoietin indicated for the treatment of anaemia associated with chronic kidney disease.
They presented the findings at the annual meeting of the European Association for the Study of Diabetes (EASD).
Professor Paul Scigalla of International Clinical Research Consulting (ICRC) – principal investigator of the analysis – commented on the study: “Diabetes is a common cause of end-stage renal failure. Patients affected will tend to have more pronounced anaemia and a reduced response to erythropoietin. The data from the Phase III studies with Retacrit suggest that it can effectively maintain haemoglobin levels in this hard-to-treat subgroup when compared with the overall haemodialysis patient population.”
Efficacy data were evaluated from analysis of two randomised, double-blind Phase III studies comparing Retacrit with epoetin alfa. In both studies, which analysed the correction and maintenance phases of renal anaemia, patients received either Retacrit or epoetin alfa intravenously.
The studies show Retacrit restored and maintained Hb levels within the acceptance ranges for both the diabetic nephropathy and the entire haemodialysis patient populations.
“Hospira is committed to providing high-quality and cost-effective treatment options. Building on our heritage in injectable generic pharmaceuticals, Hospira is pleased to provide Retacrit as a lower-cost treatment option for patients with chronic kidney disease, including those with diabetic nephropathy”, said George Blackledge, Global Director of Clinical Operations, Research & Development, Hospira.