TUESDAY, March 27 (HealthDay News) -- 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
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
Omontys should not be used in people with chronic kidney disease
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