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news.Affymax and Takeda Global Research & Development Center have presented the positive results of the Emerald Phase 3 studies, designed to assess the efficacy and safety of investigational drug peginesatide in dialysis patients with anemia due to chronic kidney disease (CKD).
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The studies demonstrated once-monthly peginesatide, compared to epoetin alfa or epoetin beta dosed up to 13 times a month, maintained Hb levels in CKD patients on dialysis with anemia.
Affymax chief medical officer Anne-Marie Duliege said the peginesatide Phase 3 program was one of the most comprehensive clinical programs to support the initial submission of a new drug application (NDA) for an erythropoiesis stimulating agent (ESA).
"We believe these data analyses continue to support peginesatide as a potential agent to treat anemia in the dialysis patient population if approved," Duliege added.
Peginesatide is a synthetic, PEGylated peptidic compound which binds to and stimulates the erythropoietin receptor and thus acts as an ESA.