FDA approves once-monthly treatment for anemic adults on dialysis

FDA has approved peginesatide (Omontys, Affymax) to treat anemia in adult dialysis patients who have chronic kidney disease (CKD).

The product will be co-marketed in the United States with Takeda Pharmaceutical Company Ltd., according to The Wall Street Journal.

Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells, which are lacking in patients with anemia. The medication 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. Omontys is administered as a once-a-month injection.

“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “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, multicenter clinical trials demonstrated the safety and efficacy of Omontys 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 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 to 12 g/dL.

The most common side effects observed in 10% or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension), and joint, back, leg or arm pain (arthralgia).

Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.

FDA approved Omontys with a Risk Evaluation and Mitigation Strategy, which added safety measures consisting of educational elements for healthcare professionals and a requirement to assess drug use data.