FDA panel backs Amgen’s anemia drug Aranesp for some kidney patients

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Outside advisors to the Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a “rescue therapy” after a doubling of stroke risk was seen in a study of 4,000 patients with mild to moderate kidney disease.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.

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

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

Aranesp brought in $2.65 billion last year, accounting for 18% 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.

Amgen shares gained $1.25, or 2.2%, to $57.96 on Monday.