European Commission Expands Aranesp Indication to Include All Paediatric Patients
ZUG, Switzerland (Sept. 28, 2007) - Amgen (Europe) GmbH today announced that the European Commission has approved Aranesp(R) (darbepoetin alfa) for the treatment of anaemia associated with chronic renal failure (CRF), also known as chronic kidney disease (CKD), in all European paediatric patients on dialysis or not on dialysis. For patients with CRF, Aranesp was previously indicated for the treatment of adults and only children >11 years of age.
"Consistent with Amgen´s ongoing commitment to improving the lives of patients with chronic renal failure and anaemia, we are delighted that the European Commission has approved expanding Aranesp´s indication to now include adult and all paediatric patients," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "Based on new data that Amgen submitted, the expanded indication is a positive demonstration of Aranesp´s longstanding favorable safety and efficacy profile in CRF patients."
Aranesp prescribing guidance is given separately for adult and paediatric patients in the updated approved Summary of Product Characteristics (SmPC). Treatment for paediatric patients younger than one year of age has not been studied. Since its introduction in 2001, Aranesp has been used in over 2.7 million patients across both its nephrology and oncology indications.
About CKD Anaemia
According to recent research, 10 percent of Europeans suffer from CKD, with many more at an elevated risk for kidney disease. CKD is a progressive and irreversible condition characterised by kidney damage and impaired kidney function. One of the most common symptoms of CKD is anaemia, which is often under-recognised and under-treated. Anaemia occurs when failing kidneys no longer produce enough erythropoietin, resulting in reduced red blood cell production and haemoglobin levels. Anaemia can have a major impact on a patient´s health and quality of life. Symptoms include fatigue, weakness, shortness of breath, difficulty concentrating or confusion, dizziness or fainting, pale skin, rapid heartbeat and feeling unusually cold.
Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anaemia associated with chronic renal failure (CRF), in adults and paediatric subjects 11 years of age or older. In 2002, the European Commission approved Aranesp for the treatment of anaemia in adult cancer patients receiving chemotherapy with solid tumours. This patient population was subsequently expanded in 2003 to include treatment of symptomatic anaemia 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 anaemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month Aranesp administration in the treatment of anaemia 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 anaemia associated with CRF, in all European paediatric 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 anaemia 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 anaemia caused by concomitantly administered chemotherapy in patients with non-myeloid 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 haemoglobin 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 haemoglobin of greater than 12 g/dL
Cancer Patients: Use of ESAs
Shortened the time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin 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 haemoglobin of greater than 12 g/dL,
Increased the risk of death when administered to target a haemoglobin 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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