Posts Tagged ‘aranesp’

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 […]

December 18th, 2012

Amgen Pleads Guilty to Misbranding Anemia Drug Aranesp

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement is announced further details about […]

October 19th, 2010

FDA Advisors Recommend No Changes for Aranesp

The FDA Cardiovascular and Renal Advisory Committee has endorsed the status quo for Aranesp (darbepoetin alfa). The committee met on Monday to discuss the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) and voted 15-1-1 against withdrawal of the indication for chronic kidney disease (CKD) patients not on dialysis. The committee also voted against adoption […]

September 15th, 2010

TREAT Analysis: Target Dosing Is Tricky

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial – and was associated with an increase in the […]