The FDA has approved peginesatide (Omontys) for the treatment of anemia in adult dialysis patients.

The approval was based on the results of two randomized, active-controlled clinical trials involving a total of 1,608 patients showing that once monthly administration of peginesatide was as safe and effective as epoetin in maintaining hemoglobin levels with the studies’ pre-specified range of 10-12 g/dL.

“Omontys represents the first new FDA-approved and marketed ESA [erythropoiesis-stimulating agent] for this condition since 2001,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

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The drug is not indicated for patients with chronic kidney disease not on dialysis or for patients with cancer-related anemia.