FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved AFFY Omontys (peginesatide)
to treat anemia, a condition in which the body does not have enough healthy
red blood cells, in adult dialysis patients who have chronic kidney disease.
Omontys is a new erythropoiesis-stimulating agent 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," said Richard Pazdur, M.D., director of the Office of
Hematology and Oncology Products in the FDA's Center for Drug Evaluation and
Research. "This new drug offers patients and health care providers the
convenience of receiving ESA therapy just once per month instead of more
frequent injections."
Two randomized, active-controlled, open-label, multi-center clinical trials
demonstrated the safety and efficacy of Omontys in patients with CKD who
were on dialysis. The trials randomly selected a total of 1,608 patients
with hemoglobin levels initially stabilized by ESA to receive either Omontys
once monthly or to continue their current ESA (epoetin) treatment. Results
showed Omontys was as safe and effective as epoetin in maintaining
hemoglobin levels within the studies' pre-specified range of 10 to 12 grams
per deciliter.
The most common side effects observed in 10 percent or more of dialysis
patients treated with Omontys were diarrhea, vomiting, high blood pressure
(hypertension) and joint, back, leg or arm pain (arthralgia).
Omontys should not be used in patients with CKD who are not receiving
dialysis or in patients with cancer-related anemia, according to the
FDA-approved labeling. It also should not be used as a substitute for red
blood cell transfusions in patients who require immediate correction of
anemia. Omontys has not been shown to improve symptoms of anemia, physical
functioning or health-related quality of life in patients with CKD on
dialysis.
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