A panel of U.S. kidney disease experts Thursday called for less-aggressive treatment of kidney disease patients -- a move that could hurt sales of lucrative anemia drugs that boost red blood cell levels but have come under scrutiny over safety concerns.
The National Kidney Foundation said its work group on kidney disease outcomes now believed that hemoglobin levels should be kept in a range of 11 to 12 grams per decaliter (gm/dl), compared with a previous range of 11 to 13 gm/dl.
The change could hurt sales of Amgen Inc.'s key anemia drugs, Aranesp and Epogen, which brought in $6.6 billion in 2006, and Johnson & Johnson's Procrit, which saw $3.2 billion in sales, although some analysts say that drug has become a less crucial product for the company.
The injectable drugs -- man-made versions of a natural protein that boost production of oxygen-carrying red blood cells -- are approved for use against anemia in people with chronic kidney failure and in cancer patients receiving chemotherapy.
The Food and Drug Administration called last month for the drugs' labels to include a "black box warning" -- the strongest possible for prescription drugs -- after studies linked high doses to an increased risk of death, blood clots, strokes and heart attacks in some patient groups.
The drugs' labels had already called for a top-end hemoglobin target of 12 gm/dl.
A spokesman for Thousand Oaks-based Amgen said the company's "patient safety and the appropriate use of our products" were top priorities and Amgen recommended that physicians and other prescribers carefully follow FDA-approved prescribing instructions.
A spokeswoman for Johnson & Johnson said the New Jersey-based company supported the Kidney Foundation's efforts and continued to advise physicians to follow the label guidelines.
Several clinical trials have shown improved quality of life for kidney patients whose hemoglobin levels were boosted as high as 16 gm/dl, said Kerry Willis, the Kidney Foundation's senior vice president for scientific activities.
The new guidelines give greater weight to potential harm from the drugs, although they do allow for hemoglobin levels as high as 13 gm/dl for certain patients, Willis said.
The Centers for Medicare and Medicaid Services is reviewing its anemia drug reimbursement.