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FDA Approves Mircera: First Renal Anemia Treatment in the US with Monthly Maintenance Dosing

BASEL, Switzerland, 15 November 2007--Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis. Mircera is the only FDA-approved 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 all CKD patients. Mircera offers the added convenience of storage at room temperature for extended time periods when... (Continued)

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Sharon Grant
Editorial Team