U.S. FDA Approves Auryxia® (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis
- Auryxia is the only oral treatment option available today developed and approved specifically for adults living with iron deficiency anemia and chronic kidney disease, not on dialysis
- One in seven adults in the U.S. is living with chronic kidney disease and more than half are estimated to be iron deficient1
Keryx Biopharmaceuticalsto hold conference call for investors at 8:00 a.m. ETto discuss the approval and the company’s third quarter 2017 financial results
With the new indication, millions of people living with chronic kidney disease have the potential to benefit from treatment with Auryxia. This medication is available today in pharmacies and covered broadly by
“More than half of the approximate 30 million people in
“We are pleased with the broad indication permitted by the
Auryxia’s supplemental new drug application (sNDA) approval was based on results from a 24-week placebo controlled Phase 3 clinical trial in 234 adults with stage 3-5 non-dialysis dependent chronic kidney disease. Patients enrolled in the trial had hemoglobin levels between 9.0 g/dL and 11.5 g/dL and were intolerant to or had an inadequate response to prior treatment with oral iron supplements. The starting dose in the study was three tablets per day taken with meals; the mean dose was five tablets per day. Importantly, during the study, patients were not allowed to receive any intravenous (IV) or oral iron, or erythropoiesis-stimulating agents (ESAs). In the study, treatment with Auryxia demonstrated significant increases in hemoglobin levels of >1 g/dL at any point during the 16-week efficacy period for the majority of patients (52.1 percent, n=61/117 compared to 19.1 percent, n=22/115 in the placebo group), a clinically meaningful result. In the trial, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile. The most commonly reported adverse events in the Phase 3 study were diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%) and hyperkalemia (7%). Results were published
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. A common complication of CKD is iron deficiency anemia. Iron is an essential mineral for the human body and is typically obtained from the diet. It is a critical component of human blood, as it is necessary to make healthy red blood cells. People with chronic kidney disease often have anemia as a result of insufficient iron (called iron deficiency anemia) and don’t produce enough hemoglobin, the component of the red blood cell that carries oxygen throughout the body. Iron deficiency anemia can negatively impact a patient’s quality of life and is associated with cardiovascular complications and increased mortality risk.2 Based on market research, Keryx estimates that nephrologists currently treat 650,000 people for iron deficiency anemia who have chronic kidney disease and are not on dialysis. There are estimated to be an additional 250,000 – 400,000 people under the care of a nephrologist who have chronic kidney disease and iron deficiency anemia but are not treated today. The prevalence and severity of iron deficiency anemia increases as kidney disease progresses.3
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.
Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development 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: 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
Conference Call Information
Keryx will host an investor conference call today at
1 Fishbane S, et al. Clin J Am Soc Nephrology 2009;4:57-61
2 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
3 Stauffer ME, et al. PLoS One. 2014;9:e84943
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Source: Keryx Biopharmaceuticals, Inc.