Further re-evaluation of ESA anemia drugs proposed by US FDA officials

In An article published in the prestigious New England Journal of Medicine yesterday, a US Food and Drug Administration official is suggesting that the agency re-evaluate the effectiveness of certain erythropoiesis-stimulating agents (ESAs), such as Amgen's Aranesp (darbepoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa), in the treatment of anemia in patients with chronic kidney disease (CKD).

'Randomized trials have endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes,' say Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, and colleagues writing in the JAMA. 'Unfortunately and unexpectedly, all results have suggested the opposite,' they added.

Among other data, the commentary referred to findings from the TREAT study of Aranesp in patients with CKD, which were published in the NEJM in October. Data from the trial showed that the rate of stroke in the group taking Aranesp was nearly double the rate of those in the placebo arm.