Positive Data from Aranesp MDS Study Announced

Amgen announced positive results from the Phase 3 ARCADE study evaluating Aranesp (darbepoetin alfa) in anemic patients with low and intermediate-1 risk myelodysplastic syndrome (MDS).

ARCADE was a randomized, multicenter, double-blind, placebo-controlled trial which evaluated Aranesp in 146 patients with low or intermediate-1 risk MDS who had not previously taken erythropoiesis-stimulating agents (ESAs) or biologic response modifiers. Patients received either Aranesp 500mcg or placebo every 3 weeks for 24 weeks. The primary endpoint was the reduction in the incidence of red blood cell transfusions at the end of Week 25.

The study met its primary endpoint, showing that patients treated with Aranesp had a reduction in the number of red blood cell transfusions at the end of Week 25. Results also showed that Aranesp significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be presented at a future medical conference and submitted for publication.

Aranesp, an erythropoiesis-stimulating agent, is currently indicated for the treatment of anemia due to chronic kidney disease (CKD) with or without dialysis and due to the effect of concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies.

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