Roche's Mircera gets nod from CHMP

Swiss drug major Roche has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending that marketing authorization be granted for Mircera, its new long-acting chemically synthesized erythropoiesis-stimulating agent (ESA), for anemia associated with chronic kidney disease. The drug received a US Food and Drug Administration "approvable" letter on March 23.

The positive opinion recommends use of Mircera in several settings: once every two weeks as a single intravenous or subcutaneous injection to increase hemoglobin levels for the initial correction of anemia in patients not currently treated with an ESA; and once monthly as a single intravenous or subcutaneous injection to maintain target hemoglobin levels for patients currently on an ESA who are converted to treatment with Mircera.

Mircera has been designed to overcome the shortcomings of currently-used ESAs. It has been shown to provide stable maintenance of hemoglobin with only 12 injections a year, which may allow overworked renal units to devote more time to other patient needs. The positive opinion is based on a submission which included data from the largest Phase II-III drug program ever carried out for anemia associated with chronic kidney disease comprising 10 global studies involving more than 2,700 patients from 29 countries.