Roche reports publication of pivotal Mircera data

Roche has presented new data from a key study of Mircera showing the conversion of patients from frequent treatment dosing to treatment once every four weeks.

Published in the Lancet, the Maintenance of Haemoglobin Excels in Intravenous Administration of CERA (continuous erythropoietin receptor activator) trial assessed the direct transfer of patients from thrice weekly treatment with erythropoiesis-stimulating agents (ESA) to near-monthly administration of Mircera once.

Trial results showed the comparable efficacy of four-weekly administration of Mircera with epoetin alfa and beta, which must be given more frequently to maintain haemoglobin concentrations.

Mircera imitates the body’s natural processes through its activity at the receptor level involved in the stimulation of production of red blood cells to facilitate the provision of stable and predictable haemoglobin levels.

Nathan Levin, medical and research director at the Renal Research Institute in New York, said: “Our findings demonstrate that Mircera can be administered once every four weeks in haemodialysis patients without sacrificing haemoglobin stability.”

He added that it is possible to generalise these trial results, recommending the use of this compound as an option to epoetin to enable patients to simplify the management of their anaemia.

In June 2007, Roche reported that the transfer of anaemia patients from treatment of ESAs to Mircera could reduce the time spent managing the condition at dialyses centres.