Amgen, the world's largest biotechnology company, will initiate a Phase 3 randomized, placebo-controlled, double-blind, multi-centre, multi-national trial to evaluate the effect of anaemia treatment with darbepoetin alfa on morbidity and mortality in patients with heart failure.
"Numerous epidemiological studies have consistently demonstrated that lower haemoglobin values, reflecting a condition known as anaemia, are associated with increased hospitalizations and mortality in heart failure patients," James Young, chairman of the Division of Medicine at The Cleveland Clinic Foundation, Cleveland, said adding, "These studies have generated a very strong hypothesis that if you raise haemoglobin values with darbepoetin alfa, you can improve outcomes in this patient population. This landmark trial will test this important hypothesis."
"Amgen's decision to proceed with its Phase 3 trial in heart failure is driven both by results from epidemiological studies, as well as by our recently completed Phase 2 pilot studies of anaemia treatment in heart failure patients which provided us with encouraging results," said Willard Dere, senior vice president for Global Development and chief medical officer at Amgen.
Aranesp is a recombinant erythropoietic protein. Amgen revolutionized anaemia treatment with the development of a recombinant erythropoietin, epoetin alfa, which is currently marketed in the US by Amgen as Epogen (Epoetin alfa) and by Ortho Biotech Products, LP, as Procrit (Epoetin alfa).