FDA Panel Votes To Keep EPO Doses Intact
Make a commentBy Ed Silverman // September 11th, 2007 // 5:30 pm
This is a big win for Amgen and Johnson & Johnson. The FDA advisory committee voted 14 to 5 in deciding that anemia meds don’t need changes in recommended doses to protect kidney patients. The panel determined that the drugs should continue to be given to boost hemoglobin to 12 grams a deciliter of blood for kidney patients on dialysis and for those who don’t receive the treatment, Bloomberg News reports.
The panel decided against lowering the recommended dose to 11 grams, which would likely have depressed drug sales. Studies have shown the drugs raised the risk of heart attack, stroke and death at high doses, and other evidence suggested a greater need for transfusions and risk of death at low doses, Bloomberg writes. The drugs, marketed as Amgen’s Epogen and Aranesp, generated $6.6 billion in sales last year. Another version, Johnson & Johnson’s Procrit, had $3.18 billion in sales last year.
“If we go below 11, we’re going to get into trouble,” said Frederick Kaskel, a pediatric nephrologist at Albert Einstein College of Medicine in New York, and a member of the panel, during deliberations.