Roche's CERA effective in CKD-based anemia

Switzerland-based drug major Roche says that data from two studies of its developmental continuous erythropoietin receptor activator (CERA) demonstrate that a lower dose of the agent was as effective as existing medications in correcting anemia in patients with chronic kidney disease. The firm added that the effect was seen irrespective of whether the subject was receiving dialysis.

The findings, which were presented at the 39th Annual Meeting of the American Society of Nephrology in San Diego, are derived from two Phase III assessments that examined the effectiveness of both subcutaneous and intravenous administration of the drug in correcting hemoglobin levels in CKD patients. Specifically, the drug was compared with epoetin alfa/beta or darbopoetin alfa in order to demonstrate non-inferiority to current therapies.

In the ARCTOS program, which provided the drug on a twice-monthly treatment schedule, the response rate to CERA was 97.5%, in comparison with 96.3% in the once-per-week darbopoetin arm. In addition, the AMICUS trial, which compared bi-monthly intravenous CERA with epoetin alpha or epoetin beta, in 181 patients receiving dialysis, showed that CERA achieved a 93.3% response rate, vs 91.3% in the standard treatment cohort.