Amgen to review use of ESA therapy in CRF patients

Amgen has announced a review of the use of erythropoiesis stimulating agents (ESAs) in patients with chronic renal failure (CRF), with the firm this week presenting data regarding its risks and benefits to advisory committees of the US Food and Drug Administration (FDA).

The presentation aimed to show that the use of such agents are safe when used properly while giving details of the key role played by such therapy in the management of anaemia symptoms in patients with CRF.

Additionally, the review set out the need for a suitable haemoglobin target of 10-12 g/dL for the management of risk and guiding of treatment, with Amgen acknowledging the potential risks seen in recent experimental studies.

Allen R Nissenson, professor of medicine, associate dean and director of the dialysis programme at the University of California, said: “ESA treatment changed the lives of CRF patients by filling an unmet medical need for a very sick population of dialysis patients.

“ESA treatment reduced the need for potentially problematic blood transfusions and improved patient exercise ability, physical functions and symptoms of anaemia.”

He added that further evaluation of the suitability of ESA therapy must take into account the level of sickness of CRF patients and their vulnerability to changes in their treatment regimens.

Last week, Amgen presented positive phase III results relating to the use of Aranesp in extensive-stage small-cell lung cancer patients receiving chemotherapy.