Creation/Revision Date: September 01, 2007
RPA LEADERS ADDRESS FOOD AND DRUG ADMINISTRATION ON SAFETY OF ANEMIA MANAGEMENT THERAPIES
The Food and Drug Administration’s (FDA’s) Cardiorenal Drug Advisory Committee (CDAC) and Drug Safety and Risk Management Advisory Committee met on September 11, 2007 to discuss the safety of Erythropoiesis Stimulating Agents (ESAs) in the treatment of anemia associated with Chronic Renal Failure. The FDA committees were tasked with considering potential label changes to ESA therapies in light of recent studies that have linked overuse of the drugs to significant safety risks and a subsequent black box warning that was placed on those product labels in March 2007.
The advisory committees voted against setting an upper range on ESA use “not to exceed ~11” for both CKD and ESRD indications which was a qualified victory for the renal community. The combined panel voted 14 – 5 against the proposed reduction in both renal indications. The panel members seemed swayed by testimony presented by industry, providers and patient advocacy groups, including RPA. RPA President Dr. Alan Kliger urged the panel to create policies and warnings that are patient-population specific; create treatment policies that expect patient response variation and do not induce overreaction to the dangers at the high end; preserve quality of life as an indication for ESA use, and respect the right of patients and their doctors to consider risks and benefits, and make best individual decisions. Other RPA leaders addressed the panel as well
including RPA Immediate Past President Dr. Robert Provenzano, speaking on behalf of DaVita and former RPA President Dr. Allen Nissenson, speaking on behalf of Amgen.
However, the panel seemed less swayed by requests to consider patient quality of life in the label indications saying the data to support such claims was inadequate, despite compelling public testimony to do so. Further, the panel discussed proposed dose algorithms as well as ways to identify ESA hyporesponders, but made no specific recommendations with regard to label changes and directed Amgen to conduct further controlled clinical studies. FDA is expected to finalize changes to the drugs’ labels in the coming weeks. FDA is not required to follow their advisory committee recommendations, but it typically does. The panel failed to make a recommendation on a specific target range, but Amgen and many panel members suggested a range of 10 – 12 g/dL.
RPA will keep the membership informed of any developments and specifically when final label changes are announced by the FDA. For more information, please contact RPA’s Director of Public Policy, Rob Blaser at (301) 468-3515.