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FDA approves Omontys for kidney disease-related anemia


SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

The FDA announced the approval of Affymax's Omontys (peginesatide), a drug belonging to the class known as erythropoiesis-stimulating agents, designed to aid the formation of red blood cells.

"Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "This new drug offers patients and healthcare providers the convenience of receiving ESA therapy just once per month instead of more frequent injections."


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