THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), in patients with chronic kidney disease (CKD). The modified language, including changes to the Boxed Warning, provides important new information for the treatment of patients with CKD who are on dialysis, as well as those not on dialysis, to inform prescribers and patients of safety risks that have been identified in clinical trials. In recognition of the different benefit-risk profiles of ESA therapy in patients on dialysis compared to patients not on dialysis, the modified labeling provides separate treatment guidance for these two CKD populations.
Specifically, for patients on dialysis, the label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL. For patients not on dialysis, physicians are asked to consider initiating ESA therapy when the hemoglobin level is below 10 g/dL, when reducing red blood cell transfusion-related risks is a clinical goal and when the rate of hemoglobin decline suggests a transfusion will be likely. Further, for those not on dialysis, physicians should reduce or interrupt the dose when the hemoglobin exceeds 10 g/dL. This guidance replaces the previous label language specifying a hemoglobin target range of 10-12 g/dL for both populations. The modified prescribing information continues to recognize the benefit of reducing the need for transfusions in CKD patients.
In addition, the Boxed Warning, Warnings and Precautions and Clinical Studies sections have been modified to advise that the use of ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions.
For complete dosing and safety information for Aranesp and EPOGEN, see the full prescribing information.
"Amgen supports the modified ESA prescribing information as it informs physicians of important safety information," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis."
The language in the prescribing information was informed by the results from clinical trials, including TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy), which targeted high hemoglobin levels (13 g/dL) in CKD patients who were not on dialysis and found an increased risk of stroke in the patients treated with ESAs compared to those receiving placebo. While TREAT was a study of patients who were not on dialysis, the modified Boxed Warning and other warnings in the label apply to all CKD patients.
Amgen is informing healthcare professionals about the revisions to the prescribing information through a joint "Dear Healthcare Professional" letter with Janssen Products, LP and will post the letter, along with the modified prescribing information on Amgen's website, www.amgen.com.
Amgen is in ongoing discussions with the FDA regarding additional post-marketing required studies to further understand the benefit-risk profile of ESAs in CKD patients on dialysis and not on dialysis.
About Aranesp and EPOGEN
Aranesp is indicated for the treatment of anemia due to CKD, including patients on dialysis and not on dialysis.
EPOGEN is indicated for the treatment of anemia due to CKD, including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusions.
Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp and EPOGEN are not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
For all patients who take Aranesp or EPOGEN, including patients with cancer or chronic kidney disease:
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