By Kasia Michalik
Since the U.S. Food and Drug Administration (FDA) approved Amgen's Epogen in 1989, there has been no other drug out there for those chronic kidney disease (CKD) patients on dialysis with anemia.
Epogen, developed by scientist Fu-Kuen Lin in 1983, was a cloned gene for human erythropoietin (EPO).
EPO is a hormone that is produced by the kidneys. It promotes the formation of red blood cells by the bone marrow. When low oxygen levels in the blood occur, there is an indication of anemia.1
Anemia, a condition that affects 95 percent of the 400,000 people in the United States who are undergoing dialysis, is one of the most common complications of CKD. Patients with kidney problems are not able to produce EPO the way a person with normal kidney function is able to.
Epogen, after 13 clinical trials on over 1,000 dialysis patients between 1985 and 1987, was the first drug that would allow CKD patients with low oxygen levels in the blood to lead semi-normal lives.
After the original FDA filing was submitted in 1987, the drug was finally approved.
"The introduction of Epogen in 1989 changed the management of anemia in patients on dialysis by increasing hemoglobin and reducing the need for blood transfusions in patients with chronic kidney disease on dialysis," said Emma Hurley, Amgen spokesperson.