FDA approves Omontys(Affymax/Takeda)for anaemia for patients on Dialysis

The FDA has approved Omontys (peginesatide) from Affymax Inc.,/Takeda to treat Anaemia, 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. The new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections. Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer�related anaemia.It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anaemia. Peginesatide has been filed at the EMA by Takeda.