LINDA A. JOHNSON AP Business Writer TRENTON, N.J. (AP) — Biotech giant Amgen Inc.’s widely used anemia drug Aranesp didn’t benefit patients with chronic kidney disease, type 2 diabetes and anemia in a large, late-stage study, the company said Tuesday. Patients in the 4,038-patient study who got Aranesp as part of their treatment fared no better than those who got a placebo on the study’s two main measures. One measure was death from any cause or heart complications such as heart attack, stroke, heart failure or hospitalization; the other measure was the length of time until the patient died or needed to go on chronic kidney dialysis. Compared with the placebo group, patients in the group treated with Aranesp suffered more strokes — a known risk of the drug. Amgen, of Thousand Oaks, Calif., said it will present full data on the study results at a medical conference later this year and will share that with regulatory authorities in various countries. Dr. Roger Perlmutter, Amgen’s head of research and development, said in a statement that the study was the biggest yet of anemia therapy in kidney patients not yet needing dialysis. Unlike a smaller recent study in a similar patient group, he said, this one did not find a higher rate of death or cardiovascular complications in patients compared with those getting placebo. Aranesp is Amgen’s third best-selling drug. Its sales have been declining recently due to limits on government reimbursements because of safety concerns, including evidence it contributed to tumor growth and decreased survival rates for some cancer patients, particularly at higher doses. U.S. sales fell 23 percent because of those issues last year, and global sales dipped 13 percent to $3.1 billion. Aranesp is approved for patients with anemia who are undergoing chemotherapy for cancer or who have kidney failure. Chronic kidney disease affects more than 26 million Americans and often is caused by progression of type 2 diabetes, the type of patients targeted in the study. Competition for anemia patients between Aranesp and Johnson & Johnson’s blockbuster Procrit, which actually is manufactured by Amgen, is fierce.
