Darbepoetin Alfa
FDA approves extended dosing of Aranesp
By Amgen
Mar 28, 2006, 19:59

Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved every-three-week dosing of Aranesp® (darbepoetin alfa) for the treatment of chemotherapy-induced anemia (low red blood cell count) in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.

"Amgen developed Aranesp to provide cancer patients with a long-acting and effective means to treat chemotherapy-induced anemia, a common side effect of chemotherapy," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of an extended dosing protocol for Aranesp is an important milestone allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens. This offers improved convenience for patients and less injection-related burden for patients and healthcare professionals compared to weekly anemia treatment."

Anemia can negatively affect patients and impact their daily activities. This can often manifest as fatigue, trouble breathing or rapid heartbeat, chest pain, dizziness or lightheadedness, inability to concentrate, headache, inability to stay warm, loss of sex drive, and pale skin. Frequent visits to the clinic for anemia treatment can result in significant time spent by patients, caregivers and healthcare providers. Reducing the number of visits required for anemia treatment with less frequent dosing and trying to synchronize anemia treatment with other naturally occurring visits could reduce the amount of patient and caregiver time required for anemia treatment.

"In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every three weeks," said Ralph Boccia, M.D., director of clinical research, Center for Cancer and Blood Disorders, Bethesda, MD. "Now, this less frequent dosing means patients can visit the doctor less frequently, which can result in less time away from loved ones and daily activities."

The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, phase 3 study that evaluated the safety and effectiveness of every-three-week administration of Aranesp. Patients with chemotherapy-induced anemia were randomized to receive 500 mcg of Aranesp every three weeks (n=353) or 2.25 mcg/kg (n=352) administered weekly for up to 15 weeks. In both groups, the starting dose was reduced by 40 percent if hemoglobin levels increased by more than 1 g/dL in a 14-day period, and Aranesp was withheld if hemoglobin levels exceeded 13 g/dL. More than 70 percent of patients in the every-three-week group required dose reductions, resulting in an average weekly dose of 125 mcg for the patients in this group.

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