The bad news continues for Aranesp (darbepoetin alfa),\u00a0Amgen’s\u00a0long-acting\u00a0erythropoietin-stimulating agent. The company today announced the top-line results of a large phase 3 heart-failure trial of the drug and said that the trial had failed to meet its primary endpoint.<\/p>\n
The\u00a0RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial<\/a>, which started in 2006, had randomized 2278 patients with heart failure and anemia to receive either Aranesp or placebo. Patients in the trial started with hemoglobin levels between 9 and 12 g\/dL. Physicians then sought to achieve hemoglobin concentrations between 13 and 14.5 g\/dL. The company said the drug did not reduce the primary composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (hazard ratio, 1.01; 95% CI, 0.90-1.13).<\/p>\n Amgen\u00a0said no new safety issues were identified in the study. The company said it would share the results with global regulatory agencies and present the results at an upcoming medical meeting.<\/p>\n Aranesp was first approved for use in 2001. It is currently indicated for the\u00a0treatment of anemia associated with chronic renal failure (CRF) in patients on dialysis and patients not on dialysis and\u00a0for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies.<\/p>\n In 2009 serious\u00a0criticism of Aranesp emerged with\u00a0the publication of the TREAT trial<\/a>, which found no clinical benefit for the drug in patients with chronic kidney disease. Results of TREAT prompted\u00a0a dramatic FDA advisory committee meeting in 2010<\/a>,\u00a0followed by\u00a0a major label revision in 2011<\/a>. In December 2012\u00a0Amgen\u00a0pleaded guilty in federal court<\/a> to U.S. government accusations that the company had marketed Aranesp for indications not approved by the FDA and other illegal marketing practices.<\/p>\n