Keryx's Supply Interruption Of Auryxia And The Delayed Approval For Amgen's Parsabiv Shake Things Up In The Renal Market

ZUG, Switzerland, Sept. 20, 2016 /PRNewswire/ -- While nephrologists are stating that the recent supply interruption of Keryx's phosphate binder, Auryxia, does not have a major impact on their practice, the challenge for Keryx will be the re-build – 48% of the nephrologists that had patients on Auryxia, anticipate a slow uptake once supply has been restored with only 6% predicting a rapid expansion.  The majority of previous non-users do not plan to use Auryxia once supply is restored.  This represents an opportunity for Vifor-FMC's Velphoro and Sanofi's Renvela to capture Auryxia patients who do not have ample supply to bridge the interruption. 

In another turn of events, the FDA served Amgen with a Complete Response Letter for Parsabiv (etelcalcetide), an IV calcimimetic similar to the company's own oral form of Sensipar. Familiarity with Parsabiv and interest in the product had been steadily growing in the months before the decision, with nephrologists predicting early and widespread adoption of the drug.  Indeed, among Medical Directors of dialysis units specifically, 27% had already begun to discuss use of Parsabiv in their dialysis units.  Nephrologists were drawn to the potential for improved SHPT outcomes due to an enhancement in compliance and a potentially favorable reimbursement environment added to the enthusiasm.

The bone and mineral metabolism market has another new therapy in the armamentarium - Opko's Rayaldee, a new oral prohormone of 25-hydroyxvitamin D₃ for the treatment of SHPT in patients with chronic kidney disease not on dialysis.  While an official launch is set to kick off before year-end, the product has been approved since June.  Less than 10% of nephrologists report being highly familiar with Rayaldee and 43% report being not at all familiar.  Among those who are at least moderately familiar, more than 40% do not view Rayaldee as an advance over other options and a similar percent anticipate challenges with reimbursement.  This lack of momentum and enthusiasm for Rayaldee does not bode well, but with the upcoming American Society of Nephrology meeting in November, Opko has an opportunity to tilt the promotional scales in their favor.

RealTime Dynamix: Bone and Mineral Metabolism is a monthly report based on the responses of approximately 100 US nephrologists.  In addition to coverage of the hyperphosphatemia and secondary hyperparathyroidism markets, RealTime Dynamix is also offered for renal anemia and hyperkalemia, providing insights into practice pattern shifts occurring in both the dialysis and chronic kidney disease settings.

About Spherix Global Insights
Spherix Global Insights is a business intelligence and market research company specializing in renal, autoimmune, neurologic and rare disease markets.  We provide clients with strategic insights leveraged from our independent studies conducted with healthcare providers and other stakeholders.

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