The U.S. Food and Drug Administration today approved Affymax’s peginesatide, also known by the brand name Omontys, to treat anemia in adult dialysis patients who have chronic kidney disease.
Peginesatide is a new erythropoiesis-stimulating agent that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Peginesatide is administered as a once-a-month injection.
“Omontys represents the first new FDA-approved and marketed ESA 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. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of peginesatide in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either peginesatide once monthly or to continue their current ESA (epoetin) treatment. Results showed peginesatide was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10% or more of dialysis patients treated with peginesatide were diarrhea, vomiting, high blood pressure and joint, back, leg or arm pain (arthralgia). ~nephrologynews&issues.com~
