EXTON, Pa.—Approximately 80 percent of nephrologists said that safety concerns surrounding erythropoiesis-stimulating agents have affected their management of anemia, according to a new report released by BioTrends Research Group.
Last year, the U.S. Food and Drug Administration placed a black box warning on ESAs—including Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit—after clinical studies raised concerns that increased ESA doses placed patients at risk.
The impact of anemia drug safety concerns has been reflected most in lower hemoglobin targets in patients, according to the survey. The U.S. Food and Drug Administration said dialysis patient’s hemoglobin levels should not exceed 12 g/dL. In addition, the report said that more than three-quarters of nephrologists said they do not anticipate any further changes to their treatments.
BioTrends Fourth Annual Nephrology TreatmentTrends Publication is based on 305 responses by clinical nephrologists to an online survey.
As for the IV iron market, the survey found that the majority of iron use is by hemodialysis patients and that the "vast majority" of nephrologists said American Regent’s Venofer and Watson’s Ferrlecit could be used interchangeably. AMAG Pharmaceuticals filed an application with the FDA to approve its new form of intravenous iron called ferumoxytol, which could be commercially available at the end of 2008. The BioTrends report found, though, that 68 percent of surveyed nephrologists said they were "not at all familiar" with AMAG’s product.
The report found that 62 percent of nephrologists said phosphorus was the most important level to keep with a target range in dialysis patients—over PTH and calcium. However, there was not an increased use of phosphate binders over the past year. The report also said that nephrologists’ phosphate-binder preference in the predialysis setting was with calcium-based binders (like Fresenius’ PhosLo), which dominated two-to-one over non-calcium agents. However, there is a shift in the dialysis setting to non-calcium-based phosphate binders (such as Genzyme’s Renagel and Shire’s Fosrenol). Renagel continues to be the market leader, according to the report, but many nephrologists are not aware of Genzyme’s new binder Renvela, which is expected to launch this year.
There was an increase in the use of vitamin D in dialysis and chronic kidney disease patients, according to the BioTrends report. The majority of nephrologists saw Abbott’s Zemplar and Genzyme’s Hectorol as interchangeable, but Zemplar continues to grow and is leading Hectorol in the dialysis and CKD markets. BioTrends also reported that more dialysis patients are using Amgen’s Sensipar and that nephrologists expect its use to continue growing with its share rising from 29 percent to 35 percent in the next three months.
