Erythropoietin Receptor Activator Provides Sustained Control of Anemia

Mircera, manufactured by Hoffmann-La Roche, Inc. (Basel, CH), is described as the first continuous erythropoietin receptor activator (CERA), which is a new class of drugs. Its activity at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs. Investigators believe that the distinct molecular interaction of this CERA plays an important role in providing targeted, stable, and sustained control of anemia.

Mircera has received marketing clearance from the [U.S.] Food and Drug Administration (FDA; Bethesda, MD, USA; www.fda.gov). Final permission to market the drug will be granted after the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has issued its recommendations on the entire class of erythropoiesis-stimulating agents (ESAs) sometime near the end of 2007.

Drugs given to correct anemia in dialysis patients include ESAs that act by stimulating the production of red blood cells. Short-acting ESAs include epoetin alfa and epoetin beta. These are generally administered three times per week. Darbepoetin alfa is a long-acting novel erythropoietin-stimulating protein (NESP) and is given once a week or once every two weeks. CERA is the first drug of a new class of compounds and has a longer half-life and a different mechanism of action at the receptor sites involved in stimulating red blood cell production. Roche reported that Mircera is the only anemia treatment originally designed to correct anemia in chronic kidney disease (CKD) patients with dosing once every two weeks and to maintain CKD patients with dosing intervals up to once monthly. CKD is considered a rising global epidemic because it is linked to two of the fastest-growing diseases--diabetes and hypertension.

"We are confident that Mircera will be approved in the United States,” said George B. Abercrombie, president and CEO of Hoffmann-La Roche, Inc., "and we understand and support the FDA's initiative to convene an advisory panel to review the use of anemia agents in the renal setting. Ultimately, this class review provides the opportunity for Roche to launch Mircera into an environment where physicians and patients will have greater clarity on how to use these treatments. Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process.”


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