EU Commission Approves Updated Prescribing Information for Aranesp

Mar 5, 2008 - Amgen (NASDAQ: AMGN) today announced that the European Commission reached its final decision to amend the prescribing information for Aranesp(R) (darbepoetin alfa) based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) in January 2008. The CHMP granted positive opinions for all centrally-authorized Erythropoiesis Stimulating Agents (ESAs) in the European Union (EU), each of which will receive European Commission Decisions. The European Commission's decision announced today is consistent with that described in Amgen's press release on Sept. 28, 2007 and the European Medicines Agency's (EMEA) announcement on Oct. 23, 2007.

A summary of key changes to the prescribing information for Aranesp are presented below. The CHMP has sought to ensure this information is consistently addressed in the Summary of Product Characteristics (SmPCs) for all ESA products in Europe.

-- Amending the SmPCs to stipulate a uniform target hemoglobin range of 10 g/dL to 12 g/dL with guidance to avoid sustained hemoglobin levels above 12 g/dL.
-- Providing guidance for dosage adjustments to maintain hemoglobin concentration between 10-12 g/dL once the therapeutic objective for an individual patient has been achieved. Patients should be monitored to ensure the lowest approved dose is used to maintain hemoglobin at a level that controls the symptoms of anemia.
-- Amending the Posology and method of administration section to recommend that Aranesp should be administered to cancer patients with symptomatic chemotherapy induced anemia (CIA) (e.g. hemoglobin concentration equal to or less than 10 g/dL (6.2 mmol/l)).
-- Amending the therapeutic indication for chronic renal failure (CRF) from "treatment of anemia associated with CRF" to "treatment of symptomatic anemia associated with CRF" in adult and pediatric patients.
-- Amending the Special Warnings to indicate ESAs have not been shown to improve overall survival or decrease the risk of tumor progression in patients with anemia associated with cancer. ESA trials have shown an unexplained excess mortality in association with high target hemoglobin concentrations (greater than 12 g/dL), including (1) shortened time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; (2) shortened overall survival in patients with metastatic breast cancer receiving chemotherapy; (3) increased risk of death when administered to target a hemoglobin of 12g/dL (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. Clinical trials in patients with CKD have also observed an increased risk of death and serious cardiovascular events when ESAs were administered to target a hemoglobin of greater than 12g/dL (7.5 mmol/l).