Omontys Approved for Anemic People With Kidney Disease
TUESDAY, March 27 -- Omontys (peginesatide) has been approved by the U.S. Food and Drug Administration to treat anemia in adults who require dialysis due to chronic kidney disease.
Anemia is characterized by a lack of enough healthy red blood cells. The newly approved drug is designed to stimulate bone marrow to produce more of these cells, reducing a person's need for a blood transfusion, the FDA said Tuesday in a news release.
Clinical testing of the once-monthly injection involved 1,608 people with abnormally low hemoglobin, a measure of anemia. The most common side effects were diarrhea, vomiting, high blood pressure and pain in the joints, back, legs or arms, the agency said.
Omontys should not be used in people with chronic kidney disease who are not on dialysis, nor those with cancer-related anemia, the FDA warned. It should also not be used as a substitute in people who require an immediate blood transfusion to treat anemia.
Omontys is marketed by Palo Alto, Calif.-based Affymax Inc.
The U.S. National Library of Medicine has more about anemia.
Posted: March 2012