Panel says anemia drug doses OK as is
GAITHERSBURG, Md. - Amgen Inc. and Johnson & Johnson's anemia drugs don't need changes in recommended doses to protect the safety of kidney patients, US advisers said.
Amgen shares rose the most in more than two years on the Nasdaq Stock Market on the news.
A panel of expert advisers to the Food and Drug Administration cast two 14-to-5 votes yesterday, finding that the drugs should continue to be given to boost hemoglobin to 12 grams a deciliter of blood both for kidney patients on dialysis and for those who don't receive the treatment.
The panel decided against lowering the recommended dose to 11 grams. Studies have shown the drugs raised the risk of heart attack, stroke, and death at high doses. Other evidence suggested a greater need for transfusions and risk of death at low doses.
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.
The antianemia drugs fall into a class of drugs known as erythropoiesis-stimulating agents, or ESAs. The drugs treat anemia by boosting the number of red blood cells.
Amgen's stock gain, was the biggest since 15 percent on July 20, 2005.
The FDA usually follows the recommendations of its advisory panels, although it isn't required to do so.
About 350,000 kidney patients in the United States are on dialysis therapy, and about 250,000 go without it, said Dan Whelan, an Amgen spokesman, in an e-mailed statement.
