ARTICLE | Clinical News

Aranesp darbepoetin alfa regulatory update

October 25, 2010 7:00 AM UTC

At a meeting to discuss results from the Phase III TREAT trial of Aranesp darbepoetin alfa from Amgen, an FDA advisory committee echoed the agency's concerns about use of the anemia drug in chronic kidney disease (CKD) patients with Type II diabetes, but decided against recommending any label changes. Although the committee agreed with FDA's conclusion from briefing documents posted ahead of the meeting that TREAT raises "considerable doubt" about the safety and advisability of using Aranesp to raise the hemoglobin in CKD patients, panel members suggested that there is insufficient information available to support more appropriate recommendations for use of the drug.

The Cardiovascular and Renal Drugs Advisory Committee voted 15-1, with 1 abstention, against removal of the indication of treatment of anemia in CKD patients not on dialysis from Aranesp's label. On the agency's question of whether to avoid use of the drug in all CKD patients with a history of stroke, 4 panelists agreed, while 10 felt that this would be too restrictive. Three members abstained. ...