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Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients

September 11, 2007

WASHINGTON, Sept. 12 /PRNewswire-USNewswire/ -- The following is a statement by KCP Chairman Dr. Edward Jones:

Yesterday's FDA Advisory Committee meeting underscores the many considerations that must be factored in to policymaking related to anemia treatment in patients suffering from chronic kidney disease. The kidney community salutes FDA for working with scientists, practicing nephrologists, and other members of the medical community to achieve a consensus on hemoglobin and dosing levels for erythropoietin-stimulating agents (ESAs) based on different patient populations. The community is unified in its belief that patient quality of care and quality of life must be taken into account as physicians treat anemia in kidney patients. Patients with chronic kidney disease and those on dialysis depend on ESAs to stimulate red blood cell production in their bodies.

Anemia-management drugs have been well demonstrated to improve quality of life for kidney patients and provide significant medical benefits. Unlike patients with cancer, patients with chronic kidney disease are permanently affected by anemia, which in turn affects their ability to engage in day-to- day activities that non-patients take for granted -- caring for their families, holding a job, and going to school. Without ESA therapy, ESRD patients may develop hemoglobin levels that are dangerously low. Before ESAs were available, blood transfusions were required in most kidney patients. Transfused patients often suffered from heart failure, iron overload, and other chronic problems.

Several studies have demonstrated improvement in the morbidity and mortality of patients with kidney disease and kidney failure by the appropriate management of their anemia. After extensive review of the results of six new studies, a National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) work group updated its Clinical Practice Guideline on Anemia this month and recommended that ESA therapy in dialysis and non- dialysis CKD patients should target hemoglobin levels in the range of 11 to 12 g/dL. These guidelines are scientifically based.

The FDA panel members reaffirmed current dosing practices and voted against limiting the upper threshold of hemoglobin levels to 11. Additionally, the FDA made it clear that the label instructions were never intended to result in EPO doses being withheld if a patient's hemoglobin level exceeded 12. Further, the committee stressed the need for small incremental dose adjustments of ESAs in an effort to minimize hemoglobin variation around the target. Dr. Ellis Unger specifically raised this as he emphasized the importance of focusing on best practices and the importance of minimizing the rate of rise and rate of fall in hemoglobin. The community urges CMS to consider these findings as they implement the Erythropoietin Monitoring Policy (EMP) used to treat anemia in ESRD patients.

The complexities of ESA dosing were readily apparent during yesterday's Advisory Commission's discussion, and we appreciate the panel's thoughtful consideration of the impact its decision will have on patients.

KCP is a nationwide alliance of representatives from the entire kidney care community, including patients and their advocates, nephrologists, nurses, dialysis care providers, and manufacturers who have joined together to improve the quality of care and quality of life for individuals suffering from kidney disease and kidney failure.

SOURCE Kidney Care Partners
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