Green Light for Existing ESA Label, but Proceed with Caution

Abstract

HYATTSVILLE, MD—In patients with chronic kidney disease (CKD) who are not on dialysis, safety signals in trials of erythropoiesis-stimulating agents (ESAs) are cause for caution, but the indication of darbepoetin alfa to treat anemia in this patient group should not be withdrawn, recommended the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee. At a meeting here in October, the committee members voted 15 to one, plus one abstention, to keep this indication. “I think it’s important to leave some room in the process for autonomy for physician and patient to make the decision as to whether to use it or not,” said Jeffrey Kopp, MD, a temporary voting member of the advisory committee, noting that there are populations who would benefit from this indication. Dr. Kopp is Captain in the US Public Health Service and is affiliated with the Kidney Disease Section of the National Institute of Diabetes and Digestive and Kidney Diseases. The advisory committee met to discuss the results of the Trial to Reduce Cardiovascular Events with Aranesp (darbepoetin alfa) Therapy, or TREAT. Like the CHOIR (Correction of Green Light for Existing ESA Label, but Proceed with Caution