Amgen has announced that the Food and Drug Administration has approved Epogen (epoetin alfa) for the treatment of anemia in children with chronic renal failure who are undergoing dialysis.
"Prior to the availability of Epogen, the majority of children with chronic renal failure were dependent on repeated blood transfusions, which can lead to adverse effects such as iron overload, a potentially serious disorder, and the development of antibodies that can preclude patients from later receiving a successful kidney transplant," said Kathy Jabs, MD, of Children's Hospital of Philadelphia and principal investigator of the pediatric clinical trial.
Epogen is a recombinant form of erythropoietin that supplements a failing kidney's inadequate supply of erythropoietin and stimulates the production of red blood cells to correct the anemia associated with chronic renal failure, Amgen said (www.amgen.com/News/news99/pressRelease991103.html).
Epogen was studied in a phase 3 randomized, multicenter, double-blind, placebo-controlled 36-week study in 113 patients. According to Amgen, patients who received Epogen experienced clinically significant increases in hematocrit levels — to at least 30%. After three months of treatment, 92% of the Epogen-treated patients no longer needed transfusions.
None of the patients were withdrawn from the use of Epogen due to adverse events, and myalgia was the only adverse event that occurred with a statistically significantly higher frequency in patients treated with Epogen.
The approval of Epogen for children with chronic renal failure came almost exactly ten years after Epogen was first approved.
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