Keryx Biopharma (KERX) Announces Presentation of Solid Auryxia Case Study Data at Kidney Week
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Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced case study data, which showed that Auryxia (ferric citrate) lowered and maintained serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis. These data were presented in a poster presentation today at the American Society of Nephrology’s 2016 Kidney Week taking place in Chicago.
Auryxia (ferric citrate) is currently indicated for the control of serum phosphorus levels in patients with CKD on dialysis.
“Data from this poster at ASN provide the first real-world evidence of the effect of Auryxia in treating hyperphosphatemia in people on dialysis,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “With Auryxia available again at pharmacies, we are pleased to be able to provide these data from the everyday practice setting that support Auryxia’s profile.”
About the Case Study Retrospective Data
Data from a retrospective chart review of 92 patients were collected by seven health care providers at multiple clinics across the U.S. Patients with CKD on dialysis who had been taking Auryxia for the control of serum phosphorus for a minimum of six months were selected to participate. The retrospective data demonstrate Auryxia’s effect in dialysis-dependent chronic kidney disease patients in routine clinical practice.
Of the 92 patient charts, 25 people were receiving peritoneal dialysis and 62 people were receiving in-center hemodialysis as part of routine clinical care. At the time of Auryxia treatment initiation, 21 patients (23%) were naïve to phosphate binders, while the remaining were treated with sevelamer (n = 37, 52%), calcium-based binders (n = 20, 28%), sevelamer + calcium (n = 10, 14%), or another binder (n = 4, 6%). Data collected included patients who took Auryxia for at least six months.
Case Study Data:Target phosphate level: 22 percent of patients were within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL before taking one dose of Auryxia (i.e. baseline). At one and six months of treatment with Auryxia, 48 percent and 65 percent of patients, respectively, achieved serum phosphorus levels within the KDOQI guideline target range.
Mean serum phosphorus levels: At baseline, patients had a mean serum phosphorus level of 6.55 mg/dL, which was lowered to 5.41 mg/dL after six months of treatment with Auryxia. The reduction in serum phosphorus levels were comparable in patients taking Auryxia who switched from sevelamer and/or calcium and in patients new to binders.
Daily tablets: At baseline, patients were taking a mean of 11.7 tablets per day on their prior phosphate binder(s). Patients who stopped their prior phosphate binder(s) and switched to Auryxia had a mean tablet burden of 7.3 tablets per day at month six of treatment with Auryxia.
Iron biomarker levels (TSAT and Ferritin): At baseline, mean hemoglobin, ferritin, and transferrin saturation were 10.6 g/dL, 734 ng/mL, and 27.1 percent, respectively. These levels increased by month three and were maintained through month six. After six months of treatment with Auryxia, these levels were 11.1 g/dL, 947 ng/mL, and 37 percent, respectively.
Discontinuations: Five patients discontinued treatment after three months of treatment: three received kidney transplants, one discontinued dialysis and one was lost to follow-up.
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.
Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.
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