Aranesp treatment achieved and maintained target hemoglobin levels and reduced incidence of red blood cell transfusions
Dec 14, 2005, 20:09
Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced interim results from the first multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial of Aranesp® (darbepoetin alfa) administered every three weeks in cancer patients with chemotherapy-induced anemia. The study revealed that Aranesp increased and maintained patient hemoglobin levels to the target level of greater than or equal to 11 grams per deciliter (g/dL) and reduced the need for red blood cell transfusions by almost half compared to placebo. The data were presented at the American Society of Hematology (ASH) 47th Annual Meeting and Exposition. (Abstract #3556)
"These results on every-three-week dosing of Aranesp are encouraging," said Kerry Taylor, MD, Mater Hospital, South Brisbane, Queensland, Australia. "If approved, this extended dosing of Aranesp may allow physicians to treat anemia on the same schedule as chemotherapy, which is frequently administered every three weeks. This may reduce the number of visits patients and their caregivers need to make to the clinic."
Researchers reported results for 386 patients (n=193 per arm) treated for up to 16 weeks and found that 77 percent of patients achieved target hemoglobin levels in the Aranesp-treated group versus 55 percent in the placebo group. Additionally, from week five to the end of treatment phase, the incidence of red blood cell transfusions was significantly lower for the Aranesp-treated group (24 percent) than for the placebo group (41 percent). The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer chemotherapy patients receiving Aranesp. Cardiovascular and thromboembolic adverse events were reported in few patients in either treatment group, and were not associated with increases in hemoglobin levels.
In May 2005, Amgen announced the 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.
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