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news.Affymax and Takeda Pharmaceutical Company have announced the FDA approval of OMONTYS (peginesatide) injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
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OMONTYS is the once-monthly erythropoiesis-stimulating agent (ESA) for anemia.
The approval was based on a new drug application, which included results from two Phase III studies.
The studies demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week, in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis.
Affymax chief executive officer John Orwin said the approval of OMONTYS provides a therapeutic alternative to treat anemia of CKD in adult patients on dialysis.
"With OMONTYS, doctors and patients will have access to a once-monthly alternative for the treatment of anemia in adult CKD patients on dialysis," Orwin added.