BURLINGTON, Mass., July 10, 2014 /PRNewswire/ -- Decision Resources Group finds that over half of surveyed nephrologists report awareness of the U.S. Food and Drug Administration's (FDA) approval of Vifor Fresenius Medical Care Renal Pharma's new phosphate binder Velphoro, which was approved by the FDA in November 2013 for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
Other key findings from the report entitled TreatmentTrends: Nephrology (US) Q2 2014:
- Bundling: Based on mean ratings, surveyed nephrologists are under the most pressure from their dialysis unit to restrict measurement of nonessential labs, to use lower doses of erythropoiesis-stimulating agents (ESAs) and to have more stringent hemoglobin targets resulting in less ESA use. Surveyed nephrologists believe that the delay of inclusion of oral dialysis drugs into the end-stage renal disease payment bundle will similarly impact future use of phosphate binders, oral iron and Amgen's Sensipar.
- IV Iron patient share in hemodialysis (HD): American Regent/Fresenius Medical Care's Venofer has significantly declined in reported HD patient share compared with this time period last year.
- Nephrologists' perceptions of late-stage compounds in clinical development: The report discusses aided familiarity, interest and percentage of patients as likely candidates for 12 renal products in development after review of product profiles. New product profiles added to this quarter's report, include:
- LaJolla Pharmaceutical's GCS-100: Nearly half of nephrologists report high interest in the product, which was higher than all other renal anemia and bone mineral metabolism products in late-stage development covered in this study.
- GSK's GSK-1278863A: Nearly one-third of nephrologists report high interest in this oral renal anemia product.
- Shield Therapeutics' ST-10: Nearly a third of nephrologists report high interest in this oral ferric iron therapy.
- Amgen's Velcalcetide: Should this intravenous therapy for secondary hyperparathyroidism (SHPT) receive FDA approval, nephrologists expect significantly higher usage in the dialysis versus the CKD non-dialysis (ND) setting.
- OPKO Health's Rayaldee: While familiarity is low, over 40 percent of nephrologists report high interest in this oral Vitamin D therapy used to treat SHPT being tested in CKD stage 3 and stage 4 patients, after review of a product profile.
Comments from Decision Resources Group Director Rob Dubman:
- "Physicians are recalling lower number of pills as one of Velphoro's primary messages from sales representatives. Not surprisingly, we have found that in this and other studies that delivery attributes are not as important compared with efficacy and safety attributes."
A special report that is expected to publish later this month entitled The Impact of New Iron-Based Phosphate Binders on the Hyperphosphatemia Market will also help manufacturers understand why and how Velphoro and Keryx Pharmaceutical's Zerenex will be used, if Zerenex receives FDA approval later this year.
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