Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.
A total of 2278 patients with systolic heart failure and mild-to-moderate anemia were randomized to darbepoetin alfa (Aranesp, Amgen) or placebo. As expected, treatment with darbepoetin alfa significantly improved hemoglobin levels. However, no significant improvements in outcomes were associated with darbepoetin alfa.
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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.
Severe blood conservation in conjunction with cardiac surgery is not associated with long-term adverse consequences, according to a new study published in Archives of Internal Medicine. ￼
Investigators from the Cleveland Clinic and the NHLBI compared 322 patients who were Jehovan’s Witnesses with an equal number of matched controls. Due to their religious beliefs Witnesses do not receive blood transfusions, and therefore “provide a unique natural experiment in severe blood conservation,” according to the authors.
Compared to patients who had transfusions, Witnesses had better short term and long term outcomes. They had fewer complications in the hospital and better survival out to 15 years.
- Perioperative MI: 0.31% for Witnesses versus vs 2.8% for controls (p = .01)
- Operation for bleeding: 3.7% vs 7.1% (p = .03)
- Prolonged ventilation: 6% vs 16% (p < .001)
- Hours in the ICU (15th, 50th, and 85th percentiles): 24 versus 24, 25 versus 48, and 72 versus 162 (p < .001)
- Survival at 5 years: 86% versus 74%
- Survival at 10 years: 69% versus 53%
- Survival at 15 years: 51% versus 35%
The investigators concluded that although they “found differences in complications among Witnesses and control groups that received transfusions, current extreme blood management strategies do not appear to place patients at heightened risk for reduced long-term survival.”
In an accompanying editorial, Victor Ferraris points out that “Witnesses who undergo cardiac surgery are likely a healthier subgroup of Witnesses because those who are believed by their surgeons to require blood transfusion to survive cardiac surgery presumably never go to the operating room.” Nevertheless, “the finding that the Witnesses who did not receive transfusions did at least as well as, if not better than, those who received a transfusion raises questions about whether more patients might benefit from surgical strategies that minimize transfusion of blood products.”
Click here to read the press release from Archives…