FDA Approves MIRCERA®: First Renal Anemia Treatment with Monthly Maintenance Dosing

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved MIRCERA (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis. CRF is commonly known as chronic kidney disease (CKD). MIRCERA is the only FDA-approved erythropoiesis-stimulating agent (ESA) to provide correction of anemia with once-every-two-week dosing. MIRCERA is also the only FDA-approved ESA to maintain stable hemoglobin levels with once-monthly or once-every-two-week dosing in CKD patients. MIRCERA offers the added convenience of storage at room temperature for extended time periods when necessary.

The outcome of an ongoing patent case will determine when patients can gain access to MIRCERA in the United States. Following approval by the European Agency for the Evaluation of Medicinal Products (EMEA), MIRCERA has already been launched in Austria, Sweden, Germany, the United Kingdom and Norway, and will continue its international rollout.

“Roche is pleased that the approved FDA label reflects the differentiating characteristics of MIRCERA,” said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. “In Europe, thousands of patients with chronic renal failure and their physicians are receiving effective, predictable and convenient anemia treatment with MIRCERA, and we are hopeful that patients and healthcare providers in the U.S. will be able to have access to MIRCERA as soon as possible, in a responsible and legal manner.”

In contrast to erythropoietin, MIRCERA is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life. MIRCERA has the longest half-life of all FDA-approved ESAs, up to six times longer than darbepoetin alfa and up to 20 times longer than epoetin.

The initial registration clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III data supporting the FDA approval for MIRCERA consisted of two correction and four maintenance studies exploring intravenous (IV) and subcutaneous (SC) MIRCERA at extended administration intervals.

In clinical trials, MIRCERA was as effective as other ESAs in correcting renal anemia in patients with CKD on dialysis and not on dialysis. Up to 97.5 percent of patients who were not currently receiving an ESA achieved target Hb levels (≧11g/dL) with once-every two week dosing of MIRCERA. Patients maintained stable Hb levels (±1g/dL) when switched to MIRCERA from a shorter-acting frequently administered ESA treatment regimen. MIRCERA has a safety profile comparable to other erythropoietic agents.