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EU Commission Approves Updated Prescribing Information for Aranesp(R)
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 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).
The full Summary of Product Characteristics is available through Amgen Medical Information.
Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anemia associated with 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 CKD patients not on dialysis. In 2006, the Aranesp label was updated to allow CKD patients on dialysis to switch from recombinant human erythropoietin (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
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of greater than or equal to 12 g/dL.
-- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of less than 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
-- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
-- Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled hypertension.
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