THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 27, 2007--Amgen (NASDAQ:AMGN) today announced that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has communicated to Marketing Authorization Holders (MAHs) of epoetins a proposal for amending prescribing information for Erythropoiesis Stimulating Agents (ESAs) in the European Union, including Aranesp(R) (darbepoetin alfa).
The CHMP's proposal includes:
-- Amending the Summaries of Product Characteristics (SmPCs) for all approved ESAs to stipulate a uniform target hemoglobin range for all epoetins 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.
-- Amending the Special Warnings to explain that trials have shown an unexplained excess mortality in association with high target hemoglobin concentrations (greater than 12 g/dL).
-- Amending the Special Warnings to say that epoetins have not been shown to improve overall survival or the risk of tumor progression in patients with anemia associated with cancer.
-- 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.
The proposed amendments are not final and Amgen will continue discussions with EMEA to finalize the language and update product labeling accordingly. Over the coming weeks Amgen will also advise prescribing health care professionals of the appropriate changes in the form of a Dear Health Care Professional (DHCP) Letter. Final approved prescribing information is expected in early 2008.
Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anemia associated with chronic renal failure (CRF), in adults and pediatric subjects 11 years of age or older. In 2002, the European Commission approved Aranesp for the treatment of anemia in adult cancer patients receiving chemotherapy with solid tumors. This patient population was subsequently expanded in 2003 to include treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. Approval was granted in 2004 for extended dosing intervals of once-every-three-weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month Aranesp administration in the treatment of anemia in chronic kidney disease (CKD) patients not on dialysis. In 2006, the Aranesp label was updated to allow CKD patients on dialysis to switch from rHuEPO one to three times a week to Aranesp every two weeks. In 2007, the Aranesp label was updated to allow for treatment of anemia associated with CRF, in all European pediatric patients on dialysis or not on dialysis.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.
Important EU Aranesp Safety Information
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum hemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information.
The most commonly reported side effects in clinical trials were arthralgia, edema, injection site pain, and thromboembolic event reactions. Prescribers are recommended to consult regional prescribing information before prescribing Aranesp, including side-effects, precautions and contra-indications.
Important U.S. Aranesp Safety Information
Use the lowest dose of Aranesp(R) that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.
Aranesp(R) and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy or radiation therapy. ESAs are not indicated for this population.
Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Aranesp(R) is not approved for this indication.
Aranesp is contraindicated in patients with uncontrolled hypertension.
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