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| |  FDA Approves Mircera (methoxy polyethylene glycol-epoetin beta) for Treatment of Renal Anemia in US With Monthly Maintenance Dosing BASEL, SWITZERLAND -- November 15, 2007 -- The U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis. Mircera is the only FDA-approved erythropoiesis-stimulating agent (ESA) to provide correction of anemia with once-every-2-week dosing. It is also the only FDA-approved ESA to maintain stable hemoglobin levels with once-monthly or once-every-2-week dosing in all CKD patients. Mircera can be stored 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 UK and Norway and will continue its international roll-out. 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,(1,2,3) up to six times longer than darbepoetin alfa and up to 20 times longer than epoetin. The phase 3 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. (2, 3,4,5,9,10,11) The initial registration clinical program for Mircera consisted of 10 global studies involving more than 2,700 patients from 29 countries.(6) In clinical trials, Mircera was as effective as commercially available agents in correcting renal anemia in patients with CRF on dialysis and not on dialysis. Up to 97.5% of patients who were not currently receiving an ESA achieved target Hb levels (>=11g/dL) with once-every 2 week dosing of Mircera.(7) Patients maintained stable Hb levels (+-1g/dL) when switched to once-monthly Mircera from a shorter-acting frequently administered ESA treatment regimen.(8,9,10,11,12) Mircera has a safety profile comparable to other erythropoietic agents. In the European Union (EU), Mircera is the first ESA approved to directly convert all CKD patient types previously treated with any ESA to once-monthly maintenance dosing. It is also the first ESA in the EU that offers a convenient dosing schedule of once every 2 weeks to correct anemia in all CKD patient types not previously treated.
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SOURCE: Roche
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