Omontys, or peginesatide, is a new erythropoiesis-stimulating agent that aids in the formation of red blood cells by stimulating bone marrow to produce more red blood cells -- usually measured as hemoglobin levels -- to reduce the need for transfusions in patients with chronic kidney disease, the FDA said.
"Omontys represents the first new FDA-approved and marketed erythropoiesis-stimulating agent for this condition since 2001," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This new drug offers patients and healthcare providers the convenience of receiving therapy just once per month instead of more frequent injections."
The trials randomly selected a 1,608 patients, with hemoglobin levels initially stabilized, to receive either Omontys once monthly or to continue their current erythropoiesis-stimulating agent (epoetin) treatment. Omontys, marketed by Affymax Inc. of Palo Alto, Calif., was as safe and effective as epoetin in maintaining hemoglobin levels within the studies' pre-specified range of 10 to 12 grams per deciliter, Pazdur said.
Omontys should not be used in patients with chronic kidney disease, who are not receiving dialysis or in patients with cancer-related anemia, the FDA said.
"It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia," the FDA statement said.