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FDA Approves New Anemia Drug for Chemo Patients

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

Aranesp maintains its level in the blood approximately three times longer than Epoetin alfa, currently marketed as EPOGEN®i and Procrit®ii, 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.

"Anemia can take a tremendous toll on patients undergoing chemotherapy, often leaving them too weak to perform routine activities. In severe cases, anemia can force doctors to interrupt chemotherapy regimens," said Robert E. Smith, Jr., M.D., president of South Carolina Oncology Associates PA and an Aranesp investigator. "Aranesp not only helps correct anemia and maintain hemoglobin levels during chemotherapy, but also helps chemotherapy patients and their physicians overcome barriers that can hinder the delivery of current anemia treatment, notably the need for frequent office visits."

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.

SOURCES:
Amgen Corporation (http://www.amgen.com)
U.S. Food and Drug Administration (http://www.fda.gov)



 




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