Aranesp dosed every three weeks achieved and maintained target hemoglobin levels
May 16, 2005 - 8:27:00 PM, Reviewed by: Dr. Sanjukta Acharya
|"This may improve patient convenience without sacrificing efficacy."
Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that new interim data from a single-arm, open label study of 1,225 cancer patients receiving chemotherapy demonstrated that Aranesp® (darbepoetin alfa) administered every three weeks was effective in increasing and maintaining patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL. Further, treatment with Aranesp reduced the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The results of the study were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8129]
"Chemotherapy is most often administered every three weeks. Our results suggest that every-three-week dosing of Aranesp at 300 mcg may allow physicians to effectively combine anemia treatment on the same schedule as chemotherapy," said Ralph Boccia, M.D., clinical associate professor of medicine, Georgetown University Medical Center. "This may improve patient convenience without sacrificing efficacy."
In the interim analysis of 1,225 cancer patients receiving 300 mcg of Aranesp every three weeks, 91 percent of patients achieved a target hemoglobin of greater than or equal to 11 g/dL, and 72 percent of patients maintained the target hemoglobin level. The mean hemoglobin was 11.5 g/dL after achieving target hemoglobin. From week five to the end of the study (week 16), only 20 percent of patients required red blood cell transfusion. The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.
In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Final results from a Phase 3 head-to-head study of Aranesp 200 mcg administered every two weeks and Epoetin alfa dosed once a week were also presented during the ASCO Annual Meeting. [Abstract #8125]
- The results of the study were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8129]
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs. Anemia occurs when there are too few red blood cells and the body's tissues are "starved" of oxygen, which can make a patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo chemotherapy in the United States; approximately 800,000 (67 percent) will become anemic. More than half of these patients report that fatigue associated with anemia affects their daily lives more than any other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of chemotherapy, it is often not recognized and frequently under-treated. In fact, 42 percent of patients with a hemoglobin level less than the recommended target level of 11 g/dL in the National Comprehensive Cancer Network® (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of recombinant erythropoietin, Epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN® (Epoetin alfa)i and by Ortho Biotech Products, L.P., as Procrit® (Epoetin alfa)ii. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. By virtue of its longer half-life, Aranesp should be administered less frequently than Epoetin alfa in patients with chronic kidney disease (CKD).
Aranesp is approved for multiple indications with varying dosage instructions in the U.S., European Union, Canada and Australia. Aranesp was approved by the FDA in September 2001 for up to every-two-week dosing for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for weekly dosing for the treatment of chemotherapy-induced anemia in patients with non-myeloid
malignancies. In 2004, the European Committee for Medicinal Products for Human Use approved Aranesp for extended dosing intervals of once every three weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and monthly in the treatment of anemia associated with CKD.
Important Safety Information
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 two-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.
Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship.
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