January 16th, 2013
No Benefit of Darbepoetin Alfa in Heart Failure Patients with Anemia
The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-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.
The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, 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).
Amgen said 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.
Aranesp was first approved for use in 2001. It is currently indicated for the treatment of anemia associated with chronic renal failure (CRF) in patients on dialysis and patients not on dialysis and for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies.
In 2009 serious criticism of Aranesp emerged with the publication of the TREAT trial, which found no clinical benefit for the drug in patients with chronic kidney disease. Results of TREAT prompted a dramatic FDA advisory committee meeting in 2010, followed by a major label revision in 2011. In December 2012 Amgen pleaded guilty in federal court to U.S. government accusations that the company had marketed Aranesp for indications not approved by the FDA and other illegal marketing practices.