FDA panel votes against anemia drug restrictions

GAITHERSBURG, Md.—An advisory panel of health experts for the U.S. Food and Drug Administration voted September 11 against setting restrictions on product labels for anemia drugs used by kidney disease patients.

The FDA charged the cardio-renal panel to look into safety issues in kidney disease patients surrounding erythropoiesis-stimulating agents, such as Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit. Recent clinical studies have shown larger doses of anemia drugs to increase a kidney disease patient’s hemoglobin levels could carry a higher risk of cardiovascular problems and death.

The FDA panel looked into setting an upper hemoglobin limit of 11 g/dL in kidney disease patients, but after hearing testimony from Amgen, patients and other industry representatives, the panel voted 14 to 5 against specifying the upper limit.

The panel vote is non-binding, but FDA officials will still take the panel’s advice in question when regulators decide whether or not to alter anemia drug product labels.

The panel said there was not enough conclusive data that could point to setting an ideal hemoglobin target for patients. Instead, the panel said it would rather the doctor have the discretion to treat patients individually.