Amgen is committed to the highest standards of patient safety. The well-being of patients is Amgen’s highest priority.

Recently, the New England Journal of Medicine published the results of experimental studies called CHOIR (conducted by Johnson & Johnson) and CREATE (conducted by Roche) that have raised questions about the wisdom of aggressive treatment of anemia in patients with chronic kidney disease (CKD) that are not on dialysis.  While we expect that discussion of these results will continue within the medical community for some time, it is important to place these results in the context of what is already known about anemia treatment.  Here are some key points to consider:

• Virtually all patients with significant kidney disease suffer from anemia to some degree, since the kidney is the principle source of natural erythropoietin, the key regulator of red blood cell production.
• Clinical studies demonstrate unambiguously that treatment of anemia in patients with chronic kidney disease, especially in those patients on dialysis, dramatically improves their quality of life. To date more than 2.5 million CKD patients on dialysis and not on dialysis have been treated with EPOGEN® (Epoetin alfa) and Aranesp® (darbepoetin alfa).
• A very substantial body of evidence, developed over the past 17 years, demonstrates that anemia associated with chronic kidney disease can be treated safely and effectively with EPOGEN® and Aranesp®, when administered according to the Food and Drug Administration (FDA)-approved dosing guidelines. In particular, the FDA-approved labels for both drugs define regimens aimed at achieving a hemoglobin target not to exceed 12 g/dL.
• In the CREATE and CHOIR studies, physicians treated patients differently than they would in standard clinical practice, and in particular sought to achieve hemoglobin targets substantially higher (> 13 g/dL) than those recommended by the FDA. In the CHOIR study, patients assigned therapy designed to achieve a target hemoglobin level of 13.5 g/dL appeared to suffer more life-threatening events than those treated conventionally.
• Amgen recommends, as we have in the past, that physicians and other prescribers follow FDA-approved dosing instructions targeting hemoglobin levels not to exceed 12 g/dL.

In response to data from the Johnson & Johnson CHOIR trial, the FDA issued a Public Health Advisory reiterating that the “maximum treatment level recommended in product labeling for all approved ESAs [erythropoietin stimulating agents] is to raise blood hemoglobin levels to no higher than 12 g/dL.” 

The advisory adds that “healthcare professionals should be familiar with the recommendations in the product labeling.” We at Amgen strongly support this FDA Public Health Advisory.

Amgen is proactively sending copies of the advisory to all nephrologists and our sales team is hand-carrying the advisory into physicians’ offices.  Amgen continues to recommend, as we always have in the past, that physicians and other prescribers use our products in accordance with their FDA-approved labels.