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news.The US Food and Drug Administration (FDA) has approved Affymax's Omontys (peginesatide) injection indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
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Omontys injection is a synthetic, pegylated, peptide-based erythropoiesis stimulating agent (ESA).
Nektar provides its partner Affymax with its proprietary PEGylation technology for use in Omontys.
Two Phase 3 dialysis studies (EMERALD 1 and 2) evaluated the safety and efficacy of Omontys, dosed once monthly, compared to epoetin alfa or beta, dosed one-to-three times per week.
In the studies, the primary efficacy endpoint was a mean change in Hb between baseline and evaluation period following entry into the study.