facebook
twitter
rss
account
search
search
 

Drug to treat anemia in dialysis patients

March 29, 2012 at 7:40 PM   |   Comments

WASHINGTON, March 29 (UPI) -- The U.S. Food and Drug Administration has approved a drug that treats anemia in adult dialysis patients who have chronic kidney disease.

Omontys, or peginesatide, is a new erythropoiesis-stimulating agent that aids in the formation of red blood cells by stimulating bone marrow to produce more red blood cells -- usually measured as hemoglobin levels -- to reduce the need for transfusions in patients with chronic kidney disease, the FDA said.

"Omontys represents the first new FDA-approved and marketed erythropoiesis-stimulating agent for this condition since 2001," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This new drug offers patients and healthcare providers the convenience of receiving therapy just once per month instead of more frequent injections."

The trials randomly selected a 1,608 patients, with hemoglobin levels initially stabilized, to receive either Omontys once monthly or to continue their current erythropoiesis-stimulating agent (epoetin) treatment. Omontys, marketed by Affymax Inc. of Palo Alto, Calif., was as safe and effective as epoetin in maintaining hemoglobin levels within the studies' pre-specified range of 10 to 12 grams per deciliter, Pazdur said.

Omontys should not be used in patients with chronic kidney disease, who are not receiving dialysis or in patients with cancer-related anemia, the FDA said.

"It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia," the FDA statement said.

© 2012 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
Recommended UPI Stories
Featured UPI Collection
trending
Celebrity Couples of 2014 [PHOTOS]

Celebrity Couples of 2014 [PHOTOS]

Most Popular
1
Schizophrenia is actually eight disorders, not one disease Schizophrenia is actually eight disorders, not one disease
2
Male pattern baldness a sign of prostate cancer risk Male pattern baldness a sign of prostate cancer risk
3
CDC: painkiller overdose deaths still rising, but not as fast CDC: painkiller overdose deaths still rising, but not as fast
4
Study: too many kids taking antibiotics Study: too many kids taking antibiotics
5
Morning exercise helps calm ADHD symptoms in children Morning exercise helps calm ADHD symptoms in children
Trending News
Video
x
Feedback