Amgen announces Arenesp prescription amendment

The European Commission (EC) has amended the prescribing information for Amgen’s Aranesp treatment for anaemia associated with chronic renal failure (CRF).

According to Amgen, the commission’s final decision came on the back of the “positive opinion” expressed by the European Committee for Medicinal Products for Human Use (CHMP) for all centrally-authorised Erythropoiesis Stimulating Agents in the EU at the start of 2008.

Among the key changes is an amendment to the Summary of Product Characteristics (SmPCs) to stipulate a “uniform target hemoglobin range” between ten and 12 g/dL and for guidance to be provided in order to avoid sustained hemoglobin levels above this maximum.

Other amendments to the prescribing information include the provision of guidance for dosage adjustments so that the hemoglobin concentration could be maintained at a level between ten and 12 g/dL when an individual’s therapeutic objective has been reached.

Amgen said the EC’s decision was “consistent” with a press release issued by the company in September last year.

The statement noted the approval by the EC that Aranesp was suitable in the treatment of anaemia associated with CRF in both adults and children.

At the time, Amgen’s senior vice-president and international chief medical officer, Dr Willard Dere, said: “The expanded indication is a positive demonstration of Aranesp’s longstanding favourable safety and efficacy profile in CRF patients.”