Darbepoetin Alfa
Interim Aranesp data suggest major response in anemic patients with MDS
Dec 13, 2005 - 8:05:38 PM

Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced updated interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp darbepoetin alfa) administered every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndrome (MDS). Low-risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 70 percent, increased hemoglobin levels and improvements in patient-reported fatigue. The data were presented at the American Society of Hematology (ASH) 47th Annual Meeting in Atlanta. (Abstract #2541)

"During the course of their disease, the majority of MDS patients develop clinically significant anemia, which can lead to fatigue and the need for red blood cell transfusions," said Janice Gabrilove, MD, professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator. "Currently, there are no recombinant erythropoietic products approved for the treatment of anemia in MDS patients. These results are encouraging."

Results for the 13-week test period were presented for 189 of 209 patients enrolled and included erythroid response, achievement of target hemoglobin, incidence of transfusion and patient reported fatigue. Sixty-nine percent of these patients (n=130) had no prior erythropoietic agent use.

In the group that had no previous treatment with an erythropoietic agent, 70 percent of patients had an erythroid response, with 49 percent classified as major response (defined as greater than or equal to 2 grams per deciliter [g/dL] increase from baseline hemoglobin or transfusion independence). Sixty-seven percent of patients achieved the target hemoglobin level of 11 g/dL. Nineteen percent in the erythropoietin-naive group had at least one transfusion during the 13-week observation period.

In the group previously treated with an erythropoietic agent (n= 59), 44 percent experienced an erythroid response, with 24 percent classified as major. Forty-five percent of patients achieved the target hemoglobin level of 11 g/dL, and 29 percent had at least one transfusion.

During the 13-week test period, 78 percent of patients experienced at least one adverse event. Seventeen percent (n= 33) of patients experienced a serious adverse event, with fatigue, asthenia, and diarrhea as the most common. Six percent (n=12) had treatment-related adverse events, with injection-site pain and diarrhea the most common (n=2 for each). No thrombotic events have been reported to date in this study.

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