FDA Approves Epogen For Treating Children
The U.S. Food and Drug Administration has approved the Amgen drug Epogen for the treatment of anemia in children with chronic kidney failure who are undergoing dialysis therapy.
Epogen elevates or maintains the red blood cell level and virtually eliminates the need for blood transfusions in patients.
The FDA’s action came almost on the 10th anniversary of Epogen’s initial approval for use with adults.
“Epogen is one of the most important improvements in the care of children with chronic renal failure in the last 20 years,” said Dr. Kathy Jabs, medical director of dialysis and renal transplantation at the Children’s Hospital of Philadelphia. “Safety is of the utmost importance in treating children; the clinical trials demonstrated that Epogen is safe in children, as it is in adults.”
Anemia associated with dialysis is often more severe in children than in adults. Before the approval of Epogen, most children with chronic renal failure were dependent on multiple blood transfusions, which could lead to adverse effects such as iron overload and the development of antibodies that can preclude patients from receiving a successful kidney transplant, Jabs said.
To accompany the Epogen treatment, Thousand Oaks-based Amgen is making available a new children’s book, “Justin’s Journey: My Life as a Kid With Kidney Disease.”
The approval of Epogen for children with kidney disease was based on the results of four clinical trials conducted at 19 U.S. sites involving 128 pediatric dialysis patients, aged 2 months to 19.
