ESAs get EU label restrictions

US biotechnology major Amgen says that the European Commission reached its final decision to amend prescribing information, placing tighter rules on the use of its blockbuster anemia drug Aranesp (darbepoetin alfa) based on an opinion from the European Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued in January. The Summary of Product Characteristics for all ESA products in Europe now stipulate a uniform target hemoglobin range of 10g/dL to 12g/dL with guidance to avoid sustained hemoglobin levels above 12g/dL. The SmPC also provides guidance for dosage adjustments to maintain hemoglobin concentration between 10-12g/dL once the therapeutic objective for an individual patient has been met. Among other recommendations, the European regulator suggests patients should now be monitored to ensure the lowest approved dose is used to maintain hemoglobin at a level that controls the symptoms.