FDA Logo Individuals suffering from chronic kidney disease (CKD) and undergoing dialysis may also be anemic. Now, the US Food and Drug Administration (FDA)has approved of the drug namely Omontys to treat anemia for CKD patients on dialysis.

This medication is a new kind of erythropoiesis-stimulating agent (ESA) that boosts the production of red blood cells. It basically triggers the bone marrow to generate more red blood cells. It is noticeable in the form of hemoglobin levels and thereby reduces the requirement of blood transfusion for CKD patients. Omontys is administered to patients as a monthly injection.

“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001. This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections,” commented Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

A total of 1,608 patients were part of the trial to gauge the safety and effectiveness of this medication. The outcomes showed that Omontys was as effective and safe as an alternative (epoetin) ESA treatment. It apparently maintained hemoglobin levels in patients between 10 and 12 grams per deciliter.

Some of the side-effects reported with its use included vomiting, leg or arm pain, high blood pressure, joint or back pain and diarrhea. As per the FDA approved labeling, Omontys is not supposed to be used for CKD patients not on dialysis and those suffering from cancer-related anemia. Alternately, it should not be as a substitute for red blood transmission for anemia patients.

However, the aforesaid medication did not apparently ease symptoms related to anemia pertaining to health quality and physical activity. The FDA team has issued its approval for Omontys along with a Risk Evaluation and Mitigation Strategy (REMS). The latter is inclusive of safety measures to aid health care professionals and other factors related to drug evaluation.

Omontys is being sold by Affymax.