FDA to Review ESAs

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In the latest word on the safety of erythropoiesis-stimulating agents (ESAs), the FDA plans a public meeting this year to reevaluate the use of the agents in the treatment of anemia in patients with chronic kidney disease. The recent findings of the TREAT trial (Trial to Reduce Cardiovascular Events with Aranesp Therapy) of the Amgen ESA Aranesp, in combination with earlier findings about ESAs, has prompted the reevaluation. The news appeared in a Jan. 7 New England Journal of Medicine (NEJM) article written by four physician-authors from the FDA’s Center for Drug Evaluation and Research.

The TREAT trial found a significant, substantial increase in the incidence of fatal or nonfatal stroke in the ESA group compared with a placebo group (5 percent of patients vs. 2.6 percent) and also a significantly higher rate of thromboembolic events among patients taking ESAs.

The NEJM authors noted that three trials showed that hemoglobin concentration targets of 14.0, 13.5, and 13.0 g/dL—and the ESA regimens used to achieve them—are harmful. According to their commentary, a future, controlled trial needs to show that assignment to any higher hemoglobin target, compared with any lower target, or to ESA dosing regimens necessary to attain these targets, prevents cardiovascular events or does not increase their likelihood.