The FINANCIAL -- Amgen on February 15 announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS at the end of the blinded 25-week study period.
Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication, according to Amgen,
Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.
MDS is among the most common type of bone marrow failure syndromes in adults.1 The disease occurs when immature blood cells do not mature in the bone marrow. Patients with MDS have fewer healthy white blood cells, red blood cells and platelets, and are at risk of infection, anemia or bleeding.2 Current treatments for MDS include blood transfusions, chemotherapy and stem cell transplants.
"We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.