Roche's Mircera is first renal anemia drug to work on a twice-monthly dosing regimen

Results from two recent studies show for the first time that chronic kidney disease patients on dialysis as well as those not on dialysis, who need correction of renal anemia, were effectively treated with Roche's Mircera (continuous erythropoietin receptor activator) on a simple twice-monthly dosing schedule, a therapeutic option that does not exist today.

The data were presented at the 39th annual meeting of the American Society of Nephrology, held in San Diego. In these two Phase III studies, the Swiss drug major's product was as effective as existing agents in correcting renal anemia, while reducing the dosing frequency two to six-fold.

In the first study, the ARCTOS program, 324 patients with CKD who were not on dialysis were randomized to either Mircera once every two weeks or darbepoetin alfa once a week subcutaneously. The response rate was 97.5% and 96.3%, respectively. After 28 weeks, patients who responded to Mircera were randomized to continue treatment twice a month or monthly with the same dose; patients on darbepoetin remained on once-weekly treatment. In a post hoc analysis, only 12.4% of patients on Mircera had one hemoglobin value greater than 13g/dL during the first eight weeks while 33.5% of patients on darbepoetin alfa exceeded this upper limit.