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Amgen Says Top-Line Results from Phase 3 Aranesp RED-HF Trial Did Not Meet Primary Endpoint

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Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 Aranesp^® (darbepoetin alfa) RED-HF^® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.  The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo.  The study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, 95 percent CI 0.90, 1.13). 

"The RED-HF Trial was designed and powered to evaluate whether the treatment of anemia could improve morbidity and mortality in systolic heart failure patients," said Michael Severino, M.D., senior vice president of Global Development and corporate chief medical officer at Amgen. "While the study did not meet its key endpoints, we thank the patients and investigators who participated in RED-HF and helped answer this important question." 

There were no new safety findings identified in the study.  The most frequently reported adverse events in the study were cardiac failure, dyspnea, diarrhea, congestive heart failure and dizziness.

These summary results will be followed by full efficacy and safety analyses, which will be shared and discussed with global regulatory agencies and submitted for presentation at an upcoming medical meeting.

Aranesp is indicated for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Aranesp has not been shown to improve quality of life, fatigue or patient well-being. 

Posted-In: News FDA

 

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