Roche announced that the FDA has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with CKD in adults, including dialysis patients and patients not on dialysis.
Mircera is the only FDA-approved erythropoiesis-stimulating agent to maintain stable hemoglobin levels with once-monthly or once-every-two-week dosing in CKD patients, and to provide correction of anemia with once-every-two-week dosing.
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However, access to Mircera for patients in the United States is blocked by an ongoing legal case; in October, a jury in U.S. District Court in Massachusetts found in favor of Amgen Inc. in a patent infringement dispute relating to Mircera. Roche is currently evaluating the possibility of an appeal, among other legal options.
