Retacrit Effective In Patients With Diabetic Nephropathy

Main Category: Diabetes
Also Included In: Blood / Hematology;  Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 08 Sep 2008 - 13:00 PDT

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Hospira (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today presented new data showing Retacrit® (epoetin zeta) is as effective as epoetin alfa (Erypo®) in achieving and maintaining haemoglobin (Hb) levels in end-stage renal failure patients with diabetic nephropathy.1 The results from an analysis of two pivotal Phase III studies were presented at the annual meeting of the European Association for the Study of Diabetes (EASD).

"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", commented Professor Paul Scigalla of International Clinical Research Consulting (ICRC), principal investigator of the analysis. "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."

Retacrit is a biosimilar erythropoietin indicated for the treatment of anaemia associated with chronic kidney disease. Efficacy data were evaluated from analyses of two randomised, double-blind Phase III studies that compared Retacrit with epoetin alfa, the reference product, in the correction and maintenance phases of renal anaemia.

The correction phase study included 27 patients with diabetic nephropathy who were receiving Retacrit during the last four weeks of treatment, and the maintenance phase study involved 37 diabetic nephropathy patients. These studies show that Retacrit restored and maintained Hb levels within the acceptance ranges for both the diabetic nephropathy and the entire haemodialysis patient populations (the 95% CI was within the ±1g/dL and ±0.6g/dL acceptance ranges for the correction and maintenance studies, respectively). Additionally, the dosage of Retacrit and epoetin alfa was equivalent for the entire population of both studies, and no significant difference in dose requirements was observed in the subgroup of patients with diabetic nephropathy.1

"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.

About the Studies

In the correction phase study, patients had anaemia at baseline (Hb <9.0 g/dL), individually corrected up to a target Hb of 11.0-12.0 g/dL; the equivalence acceptance range for mean Hb concentration for the whole study population was ±1.0g/dL during the last four weeks of the trial.

In the maintenance phase study, patients had stable Hb of 10.5-12.5 g/dL at entry, with no change in Hb >0.6 g/dL in the previous four weeks; the equivalence acceptance range for mean Hb concentration was ±0.6 g/dL for the whole study population.

In both studies, patients received either Retacrit or epoetin alfa intravenously, 1-3 times weekly, for 24 weeks.

CI: Confidence interval, an interval estimate of a population parameter.

About Retacrit

Retacrit is a biosimilar erythropoietin approved in Europe2 for the treatment of anaemia associated with chronic kidney disease (administered intravenously) and chemotherapy (administered subcutaneously). Approval was granted on the basis of strong safety and efficacy data, as well as compliance with extensive quality, clinical and non-clinical guidelines. Retacrit has been launched in several European countries including Germany, Austria, the UK, Ireland, Greece, Sweden, Norway and Portugal and is manufactured and packaged in Germany using advanced technology and following Good Manufacturing Practice (GMP) standards.

About Hospira

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States, and has more than 14,000 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more about Hospira at http://www.hospira.com

References

1. Scigalla P, Koytchev R. Efficacy of the biosimilar erythropoiesis-stimulating agent epoetin zeta to correct and/or maintain haemoglobin concentration in patients with diabetic nephropathy. Presented at EASD, Rome, Italy 7-11 September 2008. Abstract number A-08-2745-EASD.

2. European Medicines Agency (EMEA) European Public Assessment Report: Retacrit®. Available at http://www.emea.europa.eu. Accessed September 2008.

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