US FDA to review use of anemia drugs from Amgen and Johnson & Johnson; Commissioner calls for shift in traditional testing methods

The US Food and Drug Administration has said it will convene a cardiovascular and renal drugs advisory panel meeting for advice on erythropoiesis-stimulating agents (ESAs), which are used to treat anemia in patients with chronic kidney disease, because of safety concerns.

Clinical trial data, notably the TREAT study, have suggested that ESAs, such as Amgen's (Nasdaq: AMGN) Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's (NYSE: JNJ) Procrit (epoetin alfa), can increase the risk of stroke and cardiovascular problems.

Amgen reported that results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double-blind, placebo-controlled, Phase III pivotal study of patients with chronic kidney disease not on dialysis, moderate anemia and type-2 diabetes, failed to meet primary objectives of demonstrating a reduction in all-cause mortality, cardiovascular morbidity, including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia, or end-stage renal disease (ESRD; the Pharma Letter November 2, 2009).