Omontys Approved for Anemia in Dialysis Patients
The FDA announced that it has approved Omontys (peginesatide; Affymax Inc.), a once monthly injection, to treat anemia in adult dialysis patients who have chronic kidney disease (CKD).
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. A total of 1,608 patients with hemoglobin levels initially stabilized by ESA (erythropoiesis-stimulating agent) were selected to receive either Omontys once monthly or to continue their current ESA epoetin treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies' pre-specified range of 10–12g/dL.
Omontys is a new synthetic, PEGylated peptidic compound that stimulates the bone marrow to produce more red blood cells to reduce the need for transfusions in patients with CKD.
For more information call (650) 812-8700 or visit www.affymax.com.