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Roche’s Mircera Approved in European Union as CKD Treatment

July 27, 2007

Roche announced that the European Commission approved Mircera to treat anemia associated with chronic kidney disease (CKD).

The approval of Mircera results in a single marketing authorization with unified labeling for European Union (EU) countries, which is valid in all 27 EU member states, Roche said.

The Commission’s decision follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in May that recommmends granting marketing authorization, the company added.

Mircera, a continuous erythropoietin receptor activator, has a different activity at the receptor level involved in stimulating red blood cell production which more closely mimics the body’s physiologic processes. This is believed to be instrumental in delivering predictable and stable hemoglobin levels with once-monthly dosing, according to the company.

The approval is based on efficacy and safety data from a clinical program involved more than 2,700 patients from 29 countries, the company added.