ESA label changes announced

FDA on Wednesday released revisions to labels for erthryopoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia. FDA ordered Amgen (NASDAQ:AMGN) to modify the labels of Aranesp darbepoetin alfa and Epogen/ Procrit epoetin alfa to exclude their use in treating anemia associated with chemotherapy in patients being treated for cancer with the anticipation of cure. Amgen holds marketing authorizations for the products; Johnson & Johnson (NYSE:JNJ) sells Procrit for cancer indications under license from Amgen. FDA also ordered language that an ESA should not be started at hemoglobin >=10 g/dL and should be withheld if "hemoglobin exceeds a level needed to avoid transfusion." The current label states that ESA therapy can begin at hemoglobin levels >=10 g/dL if a patient is "unable to tolerate this degree of anemia due to co-morbid conditions" and should be withheld if "hemoglobin exceeds a level needed to avoid transfusion or exceeds 12 g/dL."

FDA used authority granted under the FDA Amendments Act of 2007 to order specific labeling, the agency said. Amgen must appeal the order by Aug. 4 or submit an sBLA incorporating the requested changed by Aug. 14. Amgen said in a statement that the label "is consistent with our expectations." The company said it will communicate the revised product labeling for ESAs to physicians and patients "soon." The company also said it factored the potential impact of the revised label into its updated guidance announced on July 28 (See BioCentury Extra, Monday, July 28, 2008). ...