The U.S. Food and Drug Administration (FDA) has approved methoxy polyethylene glycolepoetin beta (Mircera, Roche) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients and in those not undergoing dialysis.
Mircera is the only FDA-approved erythropoiesis-stimulating agent (ESA) to help correct anemia with dosing once every two weeks and to maintain stable hemoglobin levels with once-monthly dosing or once-every-two-week dosing in all patients with CKD.
Mircera also offers the added convenience of storage at room temperature for extended time periods when necessary.
Mircera has been launched in Europe, but it is not yet available in the U.S.
In contrast to erythropoietin, Mircera is an erythropoietin receptor activator with greater activity in vivo as well as a longer half-life. Its half-life is up to six times longer than darbepoetin alfa and up to 20 times longer than epoetin alfa.
ESAs are also discussed on page 661 of this month’s issue of P&T.
(Source: Roche, November 15, 2007.)