Darbepoetin Alfa
Final results demonstrate Aranesp dosed every two weeks is comparable to Epoetin alfa dosed weekly
May 16, 2005 - 8:22:38 PM

Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that final results of a Phase 3 randomized, head-to-head study demonstrated that 200 mcg of AranespĀ® (darbepoetin alfa) administered every two weeks is as effective as 40,000 U of Epoetin alfa dosed once a week in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8125]

"This is the largest, randomized head-to-head comparison of darbepoetin alfa dosed every two weeks to Epoetin alfa dosed weekly, as they are most often used in current oncology practice," said John Glaspy, MD, professor, David Geffen School of Medicine, University of California at Los Angeles. "Less frequent dosing provides anemia management with less frequent injections, and for patients receiving chemotherapy every two or three weeks, less frequent office visits. Our data demonstrate that less frequent injections can be accomplished without a compromise in efficacy in terms of decreased transfusion risk or improved quality of life."

In the Phase 3 head-to-head study, a total of 1,220 patients with chemotherapy-induced anemia were randomized to receive either Aranesp 200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week (n=607). The majority of patients in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. Both groups of patients had similar blood transfusion rates, patient reported outcomes, and safety endpoints.

In this study, at least 90 percent of patients in both arms of the study achieved target hemoglobin of greater than or equal to 11 g/dL. Seventy-four percent of patients in the Aranesp group remained in the target range compared to 80 percent in the Epoetin alfa group. The study's primary endpoint was designed to evaluate non-inferiority with respect to transfusion rate. Transfusions were similar in the two treatment groups (21 percent in the Aranesp group and 16 percent in the Epoetin alfa group) demonstrating non-inferiority of Aranesp and Epoetin alfa with respect to transfusion requirements.

The number and type of adverse events were similar between the two groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.

New interim data from a study of Aranesp administered every three weeks were also presented during the ASCO Annual Meeting [Abstract #8129]. 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.

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