Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp is a recombinant erythropoietic protein (proteins that stimulate production of oxygen-carrying red blood cells) that requires fewer injections than existing treatment.

Amgen revolutionized anemia treatment with the discovery of recombinant human erythropoietin in 1984, which led to the development of Epoetin alfa, currently marketed as Epogen i and Procrit ii. Building on this heritage, Amgen created Aranesp, which was developed to simplify anemia management.

Aranesp maintains its level in the blood approximately three times longer than Epoetin alfa, offering healthcare providers the ability to treat anemia related to chemotherapy with less-frequent dosing than the current standard of care.

Less-frequent dosing results in fewer injections for patients. It allows patients and caregivers to spend less time scheduling injection visits, and will free up physicians and nurses to attend to other patients and work activity.

This year, an estimated 1.2 million cancer patients will undergo cytotoxic chemotherapy in the United States; and approximately 800,000 (67%) will become anemic. Anemia is the shortage of oxygen-carrying red blood cells that fuel body function. Patients undergoing chemotherapy often suffer from anemia because chemotherapy not only attacks cancerous cells, but other cells in the body as well, including red blood cells. Aranesp stimulates the bone marrow to increase the production of red blood cells and has been shown to result in a clinically significant improvement of anemia associated with chemotherapy. Before Aranesp, physicians were limited to treating anemia associated with chemotherapy with frequent injections of Epoetin alfa or red blood cell transfusions.

Clinical studies showed that patients suffering from chemotherapy-related anemia who received Aranesp consistently reached target hemoglobin (red blood cell) levels. The studies showed Aranesp to be generally well-tolerated.

Aranesp was approved by the FDA in September 2001 for the treatment of anemia associated with chronic renal failure, also known as chronic kidney disease, for patients on dialysis and patients not on dialysis.

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea; no important differences were observed between Aranesp and Epoetin alfa.