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New Phase 2 Data Suggest Treatment of Anemia with Aranesp(R) (Darbepoetin Alfa) May Provide Clinical Benefits in Heart Failure Patients
ATLANTA--(BUSINESS WIRE)--March 13, 2006-- Amgen's Phase 3 RED-HF(TM) Trial Will Evaluate the Clinical Effect of Treating Anemia in Patients with Symptomatic Heart Failure
Amgen (Nasdaq:AMGN), the world's largest biotechnology company, announced results from a Phase 2 study that showed that treating anemia with Aranesp(R) (darbepoetin alfa) in patients with symptomatic heart failure was well-tolerated, effectively raised hemoglobin and improved patients' symptoms as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The results were presented today at the 2006 American College of Cardiology (ACC) Scientific Session.
"There is increasing evidence of a link between anemia and heart failure, and of the potential that treating anemia in heart failure patients may be beneficial over time," said Dirk J. van Veldhuisen, M.D., Ph.D., FESC, FACC, Department of Cardiology/Thoracic Surgery, University Medical Center, Groningen, Netherlands. "These data are encouraging and support the need for a large-scale, definitive trial to determine the effect of treating anemia in heart failure patients."
Based on the evaluation of the results of the Phase 2 program and observational studies, Amgen has initiated the Phase 3 RED-HF(TM) (Reduction of Events with Darbepoetin alfa in Heart Failure) Trial, a randomized, double-blind, placebo-controlled, multicenter, multinational trial that will evaluate the effect of treatment of anemia with Aranesp on morbidity and mortality in patients with symptomatic heart failure.
"Despite medical advances, heart failure and its complications are a leading cause of death and hospitalization worldwide, and there remains a significant unmet medical need for effective treatments for these patients," said Willard Dere, M.D., senior vice president for Global Development and chief medical officer at Amgen. "Amgen is committed to investigating Aranesp's potential to help heart failure patients who also suffer from anemia through the RED-HF Trial."
About the Phase 2 Study
This 26-week study enrolled 165 patients with symptomatic heart failure (New York Heart Association (NYHA) II-IV; HF duration greater than or equal to 3 months), left ventricular ejection fraction (LVEF) less than or equal to 40 percent and hemoglobin (Hb) levels of 9.0 to 12.5 g/dL. Patients were randomized to receive Aranesp subcutaneously every two weeks at starting doses of 0.75 mcg/kg (n=56) or 50 mcg (fixed dose; n=54) or placebo (n=55) to achieve and maintain a target Hb of 14.0 +/- 1.0 g/dL. The primary endpoint was the rate of Hb rise per week during the titration period. Other endpoints included change from baseline to month six in six-minute walk distance, Patient's Global Assessment (PGA), Minnesota Living With Heart Failure Questionnaire (MLHFQ), KCCQ and safety.
Investigators concluded that in patients with symptomatic heart failure and anemia, treatment with Aranesp effectively raised Hb levels, significantly improved KCCQ total symptom score (Aranesp 8.2 vs. placebo 1.5; p = 0.027) and had a similar adverse event profile as previously seen in clinical trials with Aranesp. Statistically nonsignificant improvements in PGA (Aranesp 65 percent vs. placebo 49 percent; p = 0.057), MLHFQ total score (Aranesp -10.1 vs. placebo -7.4; p = 0.413) and 6-minute walk distance (Aranesp 34.2 m vs. placebo 11.4 m; p = 0.074) were observed. Fixed dosing was as effective as weight-based dosing in raising Hb levels (difference: 0.05 g/dL/wk; 95 percent CI 0.01, 0.09), and no change was observed in NYHA class (Aranesp -0.30 vs. placebo -0.23; p = 0.473). The number of adverse events was similar across treatment groups.
Amgen Cardiovascular Clinical Trials Program
Amgen has initiated an extensive clinical trials program to study the effect of treating anemia or chronic kidney disease (CKD) complications on cardiovascular outcomes in different patient populations. In addition to the RED-HF Trial, Amgen initiated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy), an ongoing trial in diabetic patients with chronic kidney disease and anemia not requiring dialysis and will initiate a trial that will study the effect of treating the CKD complication, secondary hyperparathyroidism, with Sensipar(R)/Mimpara(R) (cinacalcet HCl) in end stage renal disease (ESRD) patients on dialysis on cardiovascular outcomes.
Anemia and Heart Failure
Heart failure and its complications are a leading cause of death and hospitalization worldwide, affecting over 23 million people worldwide and five million people in the U.S. Heart failure alone is the leading cause of hospitalization for people over the age of 65 years and causes almost one million hospitalizations every year. Approximately 20 to 30 percent of people diagnosed with heart failure also suffer from anemia, resulting in increased risk of morbidity and mortality versus patients who suffer from heart failure without anemia. Despite current, approved therapies to treat heart failure, a significant unmet medical need to treat the disease and its complications still exists.
About Aranesp(R) (darbepoetin alfa)
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of red blood cells, which carry oxygen). Amgen revolutionized the treatment of anemia with the development of recombinant erythropoietin, Epoetin alfa. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains compared to the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure, also known as chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Important Safety Information
Aranesp is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any 2-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12 - 14 g/dL, an increased incidence of thrombotic events, disease progression, and mortality was seen.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp. This has been reported predominately in patients with chronic renal failure (CRF) receiving Aranesp by subcutaneous administration. A sudden loss of response to Aranesp, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, Aranesp and other erythropoietic proteins should be withheld. Aranesp should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins.
The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
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