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Amgen's Anemia Drug Aranesp Is Safe Before Kidney Dialysis, FDA Panel Says

Amgen Inc.’s anemia treatment Aranesp is safe for use in kidney patients whose disease doesn’t require dialysis, a U.S. panel found.

Outside advisers to the Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a “rescue therapy” after a doubling of stroke risk was seen in a study of 4,000 patients with mild to moderate kidney disease. The panel recommended more studies to better explain which patients benefit from Aranesp and what dosing is ideal.

Aranesp sales have fallen by a third since 2006 over safety concerns, and doctors have curbed use in kidney patients since the stroke risks were reported last year. Eliminating pre- dialysis use may shave $200 million to $400 million from Amgen’s annual sales, or 5 to 10 cents from per-share earnings, said Michael Yee, an analyst at RBC Capital Markets in San Francisco.

“I don’t think we have enough evidence to make any changes right now,” said panel member Henry Black, a clinical professor of internal medicine at New York University School of Medicine.

The panel, meeting today in Adelphi, Maryland, voted 15-1 against ending use before dialysis and 9-5 against cutting dosing to patients with hemoglobin levels below 9 grams per deciliter of blood. Hemoglobin, an iron-containing element of red blood cells, is now targeted at 10 to 12 grams. The FDA usually follows the recommendations of advisory panels.

Amgen, the world’s largest biotechnology company, gained $1.25, or 2.2 percent, to $57.96 at 4 p.m. in Nasdaq Stock Market composite trading, the highest since April 29. The Thousand Oaks, California-based drugmaker has declined 5.5 percent in the past 12 months, compared with an 8.9 percent gain in the Standard & Poor’s 500 Index.

Anemia, Kidney Disease

An estimated 23 million U.S. adults, or about 11 percent of the population age 20 and older, have signs of kidney disease, according to the National Institutes of Health.

Anemia is common in kidney disease and can be worsened by blood loss from dialysis machines used to remove waste from the body when kidneys stop working. Aranesp and Johnson & Johnson’s Procrit are approved in the U.S. and Europe to boost levels of hemoglobin in people with anemia caused by kidney disease or chemotherapy.

Amgen added warnings about potential stroke risks to Aranesp’s prescribing information in December after publishing the study, dubbed Treat, of patients not on dialysis. The company today proposed limiting use in pre-dialysis patients to those with hemoglobin levels below 10 and at risk for blood transfusions that may jeopardize their ability to get a kidney transplant.

Drug Use

“I don’t think we know how best to use this drug in this population,” said Allan Coukell, director of health at the Pew Charitable Trusts in Washington and the panel’s consumer representative. “That’s not to say there isn’t a population who benefits. I just don’t think we know who they are or how best to treat them.”

Sales of anemia drugs have fallen since the FDA warned in 2007 that excess amounts may cause blood clots, heart attacks, strokes or deaths in kidney patients. Later research linked high doses to tumor growth and death in cancer patients, prompting limits on dosing and insurers’ reimbursement.

Aranesp brought in $2.65 billion last year, accounting for 18 percent of Amgen’s revenue. Since falling from a peak of $4.12 billion in sales in 2006, the drug is now Amgen’s third- biggest product after Enbrel for arthritis and Neulasta for preventing infections after chemotherapy.

To contact the reporter on this story: Catherine Larkin in Adelphi, Maryland, at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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