Amgen reports EU approval of Aranesp

Amgen has announced that Aranesp (darbepoetin alfa) has been approved for use in paediatric patients suffering from chronic renal failure, irrespective of whether or not they are on dialysis.

Prior to this decision, the compound was approved only for patients over the age of 11 and has been used by over 2.7 million patients in the fields of oncology and nephrology since its launch in 2001.

The new approved summary of product characteristics for the drug contains separate prescribing guidance for paediatric and adult patients.

Amgen notes that approximately ten per cent of Europeans suffer from chronic kidney disease, with others at an increased risk of contracting the condition.

Willard Dere, senior vice-president and international chief medical officer of the company, said: “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.”

He added that this expanded indication highlights the positive safety and efficacy profile of Aranesp as a treatment for patients with chronic renal failure.

Last week, Amgen received a number of proposals from the Committee for Medicinal Products for Human Use of the European Medicines Agency, including the the stipulation of a uniform haemoglobin target range and amendment of special warnings in addition to the expansion of its therapeutic indication to include children.