FDA's action came almost on the 10th anniversary of the initial approval of Epogen. Epogen is one of the most important improvements in the care of children with chronic renal failure in the last 20 years.
Anemia associated with dialysis is often more severe in children than in adults.
In the United States, the incidence of chronic renal failure in children varies from 10 to 20 new cases per year per million children, according to the United States Renal Data System. The incidence is generally higher in older children and is slightly higher in boys than in girls. Amgen has made a commitment to the nephrology community for more than a decade, and children are an important part of that community. We feel it is our responsibility to obtain comprehensive clinical information regarding Epogen's proper use and dosage for pediatric dialysis patients so that they can also experience the benefits of Epogen. 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, ages two months to 19 years old.