U.S. FDA approves new drug to treat anemia in adult patients on dialysis

The U.S. Food and Drug Administration (FDA) approved Omontys to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).

Omontys is a new erythropoiesis-stimulating agent (ESA) 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. Omontys 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, 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."

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

 VietNamNet/Xinhuanet