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The EMEA has approved Aranesp® (darbepoetin alfa) for treating anaemia associated with chronic kidney disease in paediatric patients, manufacturer Amgen has announced.
The drug was previously only authorised for treating adults, and children aged 11 and over.
According to recent research, 10% of Europeans suffer from chronic kidney disease and many more have an increased risk of it.
The condition is irreversible, with sufferers experiencing kidney damage and impaired kidney function.
One of the most common symptoms is anaemia, which occurs when failing kidneys no longer produce enough erythropoietin, resulting in reduced red blood cell production and haemoglobin levels.
Anaemic patients often experience fatigue, weakness, shortness of breath, confusion, dizziness or fainting.
Amgen senior vice-president and international chief medical officer Dr Willard Dere said: “Consistent with Amgen’s ongoing commitment to improving the lives of patients with chronic renal failure (CRF) and anaemia, we are delighted that the European Commission has approved expanding Aranesp’s indication to now include adult and all paediatric patients.
“Based on new data that Amgen submitted, the expanded indication is a positive demonstration of Aranesp’s longstanding favourable safety and efficacy profile in CRF patients.”