Keryx Biopharmaceuticals Announces Publication of Data from the Phase 3 Trial of Auryxia® (ferric citrate) for Iron Deficiency Anemia in Patients with Chronic Kidney Disease, Not on Dialysis, in the American Journal of Hematology
The article, entitled “Hemoglobin Response to Ferric Citrate in Patients with Non-dialysis-dependent Chronic Kidney Disease and Iron Deficiency Anemia,” describes associations of baseline demographic, clinical and laboratory variables with change in hemoglobin in ferric citrate-treated patients. In the phase 3 study, 234 patients were randomized to receive ferric citrate (n=117) or placebo (n=117). The full results of the phase 3 study were published in
“While patients with lower baseline measures of TSAT/ferritin values experienced a greater hemoglobin increase than those with higher baseline measures of iron storage, hemoglobin increases were also clinically significant among those with higher baseline TSAT/ferritin values, indicating that Auryxia is efficacious over a wide range of patients with CKD, not on dialysis,” said
About Iron Deficiency Anemia in People with Chronic Kidney Disease, not on Dialysis
One out of every seven adults in the U.S. has chronic kidney disease. This disease carries a significant burden with complex issues requiring many different medications. More than half of the 30 million people in
About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
- Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact
Please click here to view the Full Prescribing Information for Auryxia.
Some of the statements included in this press release, particularly those regarding the post-hoc analysis and the effectiveness of Auryxia, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the benefit seen by patients using Auryxia outside of the clinical setting; as well as our ability to successfully market Auryxia and whether we can increase adoption of Auryxia in patients with CKD on dialysis and successfully launch Auryxia for the treatment of iron deficiency anemia in patients with chronic kidney disease, not on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; our ability to continue to supply Auryxia to the market; the risk that increased utilization by
1 Fishbane S, et al. Clin J Am Soc Nephrology 2017 Jun:28(6):1851-1858;
2 Fishbane S, et al. Clin J Am Soc Nephrology 2009;4:57-61
3 Lefebvre P, et al. Curr Med Res Opin. 2006;22:1929-1937; Drueke TB, et al. N Engl J Med. 2006; 355:2071-2084; Herzog CA, et al. J Card Fail. 2004;10:467-472; Kovesdy CP, et al. Kidney Int. 2006;69:560-546; Silverberg DS, et al. Blood Purif. 2003;21:124-130
4 Stauffer ME, et al. PLoS One. 2014;9:e84943
KERYX BIOPHARMACEUTICALS CONTACT
Senior Vice President, Corporate Affairs
Source: Keryx Biopharmaceuticals, Inc.