Roche Presents Efficacy and Safety Data on Mircera in CKD

Roche presented data analyses from a large registration trial program to provide efficacy and safety information on Mircera for the treatment of renal anemia associated with chronic kidney disease (CKD) at the National Kidney Foundation Spring Clinical Meeting.

According to these analyses, Mircera with extended dosing up to once every four weeks: corrected and maintained hemoglobin (Hb) levels in patients with CKD on dialysis and not on dialysis; maintained Hb levels in dialysis patients, regardless of congestive heart failure (CHF) status as shown in a post-hoc analysis; and exhibited a safety profile that is consistent with that of commercially available erythropoiesis stimulating agents (ESAs) and typical of those associated with this patient population.

The pooled data from four Phase II and six Phase III studies evaluated the safety and tolerability of Mircera intravenous (IV) and subcutaneous (SC) in patients not previously treated with commercially available ESAs and those previously treated with commercially available ESAs. The analysis showed that the incidence of adverse events in the Phase II and III safety population was similar between Mircera and reference groups, and typical of those associated with this patient population. In addition, Mircera was shown to have a safety profile consistent with that of reference ESAs.

Another retrospective analysis of two Phase III studies evaluated the efficacy and tolerability of Mircera IV and SC administered once every two weeks or once every four weeks in patients with or without CHF who were on dialysis and were directly converted from epoetin alfa or beta. The post-hoc analysis showed that Mircera, administered at extended dosing intervals, was effective in maintaining stable Hb levels in dialysis patients with and without CHF who were directly switched from shorter-acting ESAs.

The last analysis was an overview of six global studies in approximately 2,400 patients that compared Mircera with epoetin alfa or beta and with darbepoetin alfa. This overview showed that the efficacy of Mircera was comparable to that of the comparator agents, but Mircera required less frequent administration.

Roche's biologics license application for Mircera for renal anemia is currently under FDA review.