Amgen Issues Statement on Update to U.S. Prescribing Information for Erythropoiesis-Stimulating Agents (ESAs)
On December 16, 2009, Amgen updated the boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), to reflect an increased risk of stroke when ESAs are administered to chronic renal failure patients to target hemoglobin levels of 13 g/dL and above. The update was made based on results from the recently completed clinical study, TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double-blind, placebo-controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type-2 diabetes. In addition, the Warnings section has been updated to include a description of TREAT and the increased risk of stroke found in the study.
Amgen is informing healthcare professionals about the revisions to the U.S. ESA prescribing information through a joint "Dear Healthcare Professional" letter with Centocor Ortho Biotech Products, L.P.
Amgen is committed to ensuring physicians and patients have the latest information about ESAs in order to make appropriate treatment decisions. We made this timely change to the ESA labeling to ensure physicians are aware that TREAT revealed a higher magnitude of stroke than seen in previous clinical trials. The results of TREAT reinforce the need to follow the approved label guidance.
Concurrently, we are conducting further analyses of the recently reported TREAT data and are continuing discussions with global regulatory authorities to determine if additional labeling changes should be considered.
On October 30, Amgen announced the publication and presentation of the results of TREAT, a superiority study designed to demonstrate improved cardiovascular outcomes in patients with CKD not on dialysis, moderate anemia and type-2 diabetes treated to a target hemoglobin level of 13 g/dL compared to placebo. The study failed to meet its primary objectives of demonstrating a reduction in all-cause mortality, cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia), or end-stage renal disease (ESRD). Among the components of the primary cardiovascular composite endpoint, the risk of stroke increased by almost two-fold in patients in the Aranesp arm. Although stroke is a recognized risk with ESA therapy, and has been identified in warnings in U.S. labeling since 2001, the risk observed in TREAT is of higher magnitude than that seen in previous clinical trials in CKD patients not on dialysis.
The updated labels are available on the product Web sites: www.epogen.com and www.aranesp.com.
Contact:
Amgen
Emma Hurley, 202-585-9647 (media)
John Shutter, 805-447-1060 (investors)
