Keryx Aims For Ironclad Hold On Hyperphosphatemia Market
Recently-approved (and still un-trade named) phosphate binder ferric citrate could unseat the market leader due to its unique ability to increase iron in patients, firm believes, although it didn’t get the full set of labeling claims it sought.
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Keryx set to pursue expanded FDA labeling of its phosphate binder Auryxia to pre-dialysis patients with iron deficiency, a patient population already approved for treatment in Europe.
Keryx plans to file an NDA for phosphate binder Zerenex during the second quarter, with an EU filing to follow by mid-year. In a long-term Phase III study, the candidate met its primary efficacy endpoint as well as several secondary endpoints.
Company set to price drug up to 20% below Genzyme's market leading Renvela/Renagel franchise, and ponders impact of new Medicare bundling regime for phosphate binders used in end-stage renal disease.