Biologic drug Mircera was approved by European Union authorities on May 25th for treatment of anemia in chronic kidney disease patients.

Swiss drugmaker Roche said it had received a positive opinion for Mircera from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The European Commission customarily follows the recommendations of the CHMP, and formal approval to market Mircera in member countries is expected within two to three months.

The good news came just a week after the U.S. Food and Drug Administration delayed action on approval of Mircera for use in the United States.

The FDA gave the company a draft of the drug's labeling, but Roche said final FDA action was not expected before an agency advisory panel meets in the fall to discuss concerns over the safety and potential overuse of this class of anemia drugs in kidney patients.

Mircera is a synthetic erythropoiesis-stimulating agent (ESA) which will compete with Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit.

According to Roche, Mircera is the first biologic able to correct anemia in chronic kidney disease patients with dosing once every two weeks, and the first to maintain these patients on monthly dosing intervals.

Dan Kemmler, Roche commercial director for Mircera, said he expects the biologic to be adopted rapidly by physicians in Europe and become the best-selling anemia treatment for patients with kidney failure.