The Renal Anemia Market is on the Cusp of Change Beginning with the FDA Approval of Keryx Biopharmaceutical's Auryxia for the Treatment of Iron Deficiency Anemia (IDA) in Adults with Chronic Kidney Disease, Not on Dialysis (CKD-ND)
EXTON, Pa., Nov. 7, 2017 /PRNewswire/ -- Earlier today Keryx announced the second approval for Auryxia (ferric citrate) to treat iron deficiency anemia in patients with chronic kidney disease. It is the first oral iron product to be developed and approved specifically for this indication. Auryxia was originally approved as a phosphate binder for patients on dialysis in September 2014. So what does this mean for Auryxia and what does it mean for the treatment patterns in renal anemia in the CKD-ND setting?
According to on-going quarterly market research conducted by Spherix Global Insights in both the renal anemia and hyperphosphatemia markets, the approval represents a significant opportunity for Auryxia. In the most recent findings from RealTime Dynamix: Renal Anemia, based on a survey of 194 nephrologists surveyed in September, 67% agree that IV iron is inconvenient for CKD-ND patients, but also lament that results with oral iron tend to be unsuccessful due to tolerability and efficacy issues. 80% of the surveyed nephrologists indicated that this approval would lead to an increase in their use of Auryxia.
The challenge for Keryx, beyond the ever-present reimbursement hurdles, will be to distinguish Auryxia as an IDA treatment, independent of its phosphate binder indication in dialysis patients. Indeed, among the nephrologists already prescribing Auryxia in the CKD-ND population, the majority prescribe it for the dual effects of phosphate lowering and favorable impact on anemia parameters. Close to half of those surveyed also agreed that "If Auryxia is approved for IDA in CKD non-dialysis, I would only use it if the patient also needed a phosphate binder." To Keryx's advantage is the current level of promotion overall for Auryxia, which reportedly has increased recently and which vastly outpaces that of IV iron brands such as Daiichi-Sankyo/American Regent/Vifor's Injectafer and AMAG Pharmaceutical's Feraheme. There is little to no promotion of oral iron brands, most of which are generic, leaving Keryx an open runway.
Advancing through the pipeline is a new and novel class of oral anemia treatments known as hypoxia inducible factor -1 (HIF) inhibitors such as roxadustat (AstraZeneca/Astellas/Fibrogen), vadadustat (Akebia Therapeutics/Otsuka), and daprodustat (GSK). While nephrologists in the trenches are slowly gaining familiarity with this new class, the excitement about a new approach to treating anemia, beyond the traditional ESA and iron combination, is mounting. More than half of the nephrologists agree with the statement "The availability of HIF inhibitors will revolutionize the way anemia is treated in pre-dialysis patients."
How will these new agents fit in the renal anemia treatment algorithm? According to Jay Wish M.D., Professor of Clinical Medicine at Indiana University School of Medicine, "Although the HIF stabilizers hold promise for anemia treatment in patients with CKD and especially those not on hemodialysis, such patients still may require some form of iron supplement once endogenous iron stores are mobilized. Since a significant fraction of CKD-ND patients are actually iron depleted, there may be scant iron stores for a HIF stabilizer to mobilize. Even if HIF stabilizers improve absorption of oral iron, it may not be sufficient to meet the needs of increased erythropoiesis, so the combination of HIF stabilizers and a more bioavailable oral iron supplement may be desirable."
To what extent Auryxia and, if approved, the HIF inhibitors will disrupt the renal anemia market will be followed in the on-going quarterly series of RealTime Dynamix: Renal Anemia. The next wave of this study will be published in December.
RealTime Dynamix(TM): Renal Anemia is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development.
About Spherix Global Insights
Spherix Global Insights is an independent market intelligence agency, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.
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