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news.Roche has said that the FDA has approved Mircera for the treatment of anaemia associated with chronic kidney disease both in patients on dialysis and those not on dialysis.
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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 all chronic kidney disease (CKD) patients. Mircera offers the added convenience of storage at room temperature for extended time periods when necessary, the company says.
William Burns, CEO Roche Pharma, said: “The FDA approval for our innovative anaemia treatment Mircera is another significant milestone for Roche, Mircera has now been reviewed and approved by both the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA), two of the world´s leading regulatory authorities.”