FDA Clears Once-Monthly Drug for Anemia in Dialysis Patients

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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.

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

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