The drug is a new erythropoiesis-stimulating agent (ESA) that helps in the formation of red blood cells. Patients with anemia do not have enough healthy red blood cells.
"Ask your doctor whether you could benefit from the new drug."
Omontys, marketed by Affymax Inc. of Palo Alto, Calif., stimulates bone marrow, coaxing it to produce more red blood cells and reducing the need for blood transfusions in patients that already are receiving kidney dialysis.
Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, noted that the medication is the first ESA approved by the FDA since 2001. He said it would offer doctors and patients convenience by allowing them to opt for a single monthly injection instead of more frequent injections.
The medication was approved following a pair of randomized, active-controlled, multi-center clinical trials demonstrated that the drug was both safe and effective for anemia patients on dialysis.
During the trial 1,608 patients were randomly selected to receive Omontys monthly by injection or their current ESA treatment of Epogen (epoetin). Participants had hemoglobin levels that had previously been stabilized with other ESAs. Hemoglobin is a protein that carries oxygen in red blood cells.
Investigators found that the new drug was as safe and effective as epoetin in managing hemoglobin levels within a pre-set range.
The most common side effects, that affected fewer than 10 percent of patients include diarrhea, vomiting, high blood pressure, and joint, back, leg or arm pain.
The drug is designed only for anemia patients receiving kidney dialysis, and should not be taken by patients with chronic kidney disease who do not receive dialysis or with cancer-related anemia, the FDA label notes. It is not designed as a substitute for blood transfusions in patients requiring immediate care for anemia.
Omontys has not been shown to improve anemia symptoms, physical functioning or health-related quality of life in patients with chronic kidney disease on dialysis.