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Press Release

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

April 4, 2018 at 8:00 AM EDT

BOSTON, April 04, 2018 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, today announced the publication of a post-hoc analysis of Auryxia phase 3 trial data for iron deficiency anemia in adult patients with chronic kidney disease (CKD), not on dialysis, in the online issue of 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 January 2017 in the Journal of the American Society of Nephrology.1 This post-hoc analysis assessed the intent-to-treat population (ferric citrate, n=117; placebo, n=115). Baseline characteristics were similar across treatment groups. Results of this multivariable regression analysis show the following variables were associated with greater hemoglobin increases from baseline at 16 weeks: ferric citrate treatment (p<.0001), lower baseline hemoglobin (p=.0160), higher serum albumin (p=.0007), lower intact fibroblast growth factor 23 (FGF23) (p=.0024), and lower transferrin saturation (TSAT) (p=.0189). Treatment interactions were observed for TSAT and ferritin only.

“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 John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “These findings support the current KDIGO treatment guidelines that recommend a trial of oral iron in patients with iron deficiency anemia and chronic kidney disease.”

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 the United States living with CKD are estimated to be iron deficient2 and 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.3 The prevalence and severity of iron deficiency anemia increases as kidney disease progresses.4

About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. Auryxia tablets were designed to contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (one per meal). For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)

CONTRAINDICATION

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.

ADVERSE REACTIONS

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%)

SPECIFIC POPULATIONS

  • 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 Keryx Biopharmaceuticals at 1-844-445-3799.

Please click here to view the Full Prescribing Information for Auryxia.

About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc., headquartered in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. This dedication has resulted in two FDA-approved indications for Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com.

Forward-Looking Statements
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 Medicare Part D subscribers will increase our gross-to-net adjustment greater than we anticipate; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

References
1   Fishbane S, et al. Clin J Am Soc Nephrology 2017 Jun:28(6):1851-1858;
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
Amy Sullivan
Senior Vice President, Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com

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Source: Keryx Biopharmaceuticals, Inc.