The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said 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 2,278 patients with heart failure and anemia to receive either Aranesp or placebo.
Click here to read the full story on Forbes.
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 pending civil suits against Amgen will be unveiled. The acting US Attorney said that the terms of the agreements will include multiple measures to insure that Amgen complies with regulations. The measures will mean that Amgen “won’t view this as the cost of doing business,” he said in a press conference.
The agreement includes $150 million for criminal fines and penalties and an additional $612 million civil settlement. In 2011 Amgen reported $2.3 billion in sales for Aranesp.
Aranesp is approved to treat anemia in chemotherapy patients and in anemia patients with chronic kidney disease. The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Although it had been the subject of earlier questions, serious criticism emerged with the publication in 2009 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.
Click here for a PDF of the US Attorney’s Explanation of the Charges.