Amgen submits Epogen testimony

Amgen has announced that it has submitted testimony relating to the administration of Epogen (epoetin alfa) to the house ways and means subcommittee in the US.

This submission has been received as part of the hearing entitled Ensuring Kidney Patients Receive Safe and Appropriate Anaemia Management Care, with the firm reporting that the use of the compound has been appropriate over time.

Amgen reported that the majority of Epogen use in dialysis is appropriate, noting that 83 per cent of patients haemoglobin excursions exceeding 12 g/dL drop below this level within three months.

Furthermore, the company presented the analysis of new data showing more conservative dosing with Epogen following the announcement of the erythropoietin monitoring policy in November 2005 and changes to erythropoiesis stimulating agent product labelling in March 2007.

Joshua Ofman, vice-president of global coverage and reimbursement at Amgen, said: “Amgen is committed to the highest standards of patient safety.

“The well-being of patients is Amgen’s top priority as is the appropriate use of all of our products.”

He added that there does not seem to be a convincing reason to make major changes to the dialysis payment system, with the full impact of recent modifications not yet fully established.

In March 2007, Amgen announced an update of the safety information for Epogen, including a boxed warning in the prescribing information for the drug.