Good anemia control in CKD for Shire's Dynepo

UK drugmaker Shire says that its drug Dynepo (epoetin delta), the first anti-anemia treatment produced in a human cell line, can effectively control anemia in patients with chronic kidney disease, according to two Phase III studies presented at the 42nd annual meeting of the European Association for the Study of Diabetes.

Shire noted that patients with kidney disease as a result of diabetes (diabetic nephropathy) were amongst the population treated effectively with this new treatment, adding that Dynepo is the first erythropoiesis-stimulating agent to be produced by gene-activation technology in a human cell line and accordingly differs from all other available ESAs, which are all recombinant proteins produced in Chinese hamster ovary cells.

The two large-scale Phase III studies demonstrated that the agent can effectively maintain hemoglobin at target levels (10g/dL - 12g/dL) over a long period of time (up to 52 weeks) when administered either intravenously or subcutaneously, with the data also showing overall efficacy when Dynepo was used in various types of patients with anemia associated with CKD - whether they require dialysis or not.