Breaking News
July 16, 2018 - Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
July 16, 2018 - NSAIDs shown to have causal role in cardiovascular risk of patients with osteoarthritis
July 16, 2018 - PET scan tracer predicts success of cancer ‘vaccine’ | News Center
July 16, 2018 - Parents struggle with what to do when their child has headache, shows study
July 16, 2018 - Outrageous or overblown? HHS announces another round of ACA navigator funding cuts
July 16, 2018 - Weight loss surgery may impact individual’s risk of developing cancer, shows study
July 16, 2018 - Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
July 16, 2018 - Restoring epigenetic balance reinstates memory in flies with Alzheimer’s disease symptoms
July 16, 2018 - Magnetized wire could be used to detect cancer in people | News Center
July 16, 2018 - Non-surgical management found to be feasible option for penetrating kidney trauma
July 16, 2018 - California clinic screens asylum seekers for honesty
July 16, 2018 - FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
July 16, 2018 - Can nanotechnology help treat Alzheimer’s?
July 16, 2018 - Researchers identify protein essential for making stem cells | News Center
July 16, 2018 - Radiologist discusses causes, treatments of varicose veins
July 16, 2018 - Researchers develop nanostructured surface to accelerate wound healing after dental implants
July 16, 2018 - New non-invasive procedure to reposition kidney stones could benefit astronauts
July 16, 2018 - Attending Surgeon Influences Genetic Testing in Breast Cancer
July 16, 2018 - Medical doctors with addictions fear professional repercussions if they seek treatment
July 16, 2018 - 5 Questions: John Ioannidis calls for more rigorous nutrition research | News Center
July 16, 2018 - SUSU scientists develop rehabilitation device for people with lower limbs injuries
July 16, 2018 - Researchers find definite increase in scooter-related injuries
July 16, 2018 - Researchers solve mystery of final blood group system
July 16, 2018 - Researchers develop near-infrared fluorophores-based PDT to cure cancer with less side effects
July 16, 2018 - Traumatic brain injury biomarker could help predict patient prognosis
July 16, 2018 - Researchers to investigate role of hormones in mosquito’s ability to use human blood for egg production
July 16, 2018 - AHA: Doctor Makes Lifesaving House Call in His Own Home
July 16, 2018 - Nearsightedness – Genetics Home Reference
July 16, 2018 - Study shows biomarker panel boosts lung cancer risk assessment for smokers
July 16, 2018 - Researchers find link between bereavement during pregnancy, child’s mental health | News Center
July 16, 2018 - Legalizing same-sex marriage has meaningful effects on health care access for sexual-minority men
July 16, 2018 - New York to allow medical marijuana as substitute to opioids
July 16, 2018 - Reducing tapeworm infection could improve academic performance, reduce poverty | News Center
July 16, 2018 - Researchers describe key role of enzyme in regulating immune response against Chagas disease parasite
July 16, 2018 - Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV
July 16, 2018 - Do Racial and Gender Disparities Exist in Newer Glaucoma Treatments?
July 16, 2018 - Antibodies may predict transplant rejection risk
July 16, 2018 - New center sets out to stop disease before it starts | News Center
July 16, 2018 - FDA warns consumers about criminals sending fake warning letters
July 16, 2018 - Residential segregation linked with racial disparities in firearm homicide fatalities
July 16, 2018 - UW-Madison researchers develop new method to track Parkinson’s damage in the heart
July 16, 2018 - New approach to cultivate hypoallergenic tomato and strawberry varieties
July 16, 2018 - Smoking associated with delayed shinbone healing
July 16, 2018 - Sheila Dolezal, ‘team player extraordinaire,’ wins 2018 Amy J. Blue Award | News Center
July 16, 2018 - Advanced Prostate Cancer Variant More Common Than Thought
July 16, 2018 - New ways to conquer sleep apnea compete for place in bedroom
July 16, 2018 - Renowned microbe hunter Stanley Falkow dies at 84 | News Center
July 15, 2018 - FDA Slaps Stronger Warnings on Potent Class of Antibiotics, Fluoroquinolones
July 15, 2018 - Don’t let depression keep you from exercising
July 15, 2018 - Student research symposium showcases curiosity and scholarship | News Center
July 15, 2018 - Heavy smokers have increased risk of heart rhythm disorder, shows study
July 15, 2018 - Parents who had severe trauma, stresses in childhood more likely to have kids with behavioral health problems
July 15, 2018 - At colloquium, a range of views on value of predictive algorithms | News Center
July 15, 2018 - Pittcon invites oral and poster presentations for 2019 Technical Program
July 15, 2018 - Virtual reality could offer psychotherapy for fear of heights, study shows
July 15, 2018 - Retooled vaccine raises hopes as a lower-cost treatment for Type 1 diabetes
July 15, 2018 - Kolon TissueGene To Start US Phase III Clinical Trial For Invossa
July 15, 2018 - Study finds prenatal marijuana use can affect infant size, behavior
July 15, 2018 - Howard Chang named HHMI investigator | News Center
July 15, 2018 - Study shows tailored mental health services improve wellbeing of emerging adults
July 15, 2018 - A bright future might help teens steer clear of violence
July 15, 2018 - Stanford Medicine magazine explores the art, science of listening and hearing | News Center
July 15, 2018 - New study tracks how the brain turns simple sensory inputs into meaningful categories
July 15, 2018 - Deadlier subtype of metastatic prostate cancer found to be common than previously thought
July 15, 2018 - UZH scientists identify enzyme that controls cell division
July 15, 2018 - Unhealthy Food Behaviors May Signal Eating Disorder in Teen
July 15, 2018 - Study raises doubts on a previous theory of Parkinson’s disease
July 15, 2018 - Grant awarded to study whether stem cells can treat urinary incontinence | News Center
July 15, 2018 - Imaging techniques may help assess immune system recovery in HIV patients
July 15, 2018 - Machine-learning may aid in diagnosis and treatment of mental health disorders
July 15, 2018 - ‘Skin Cancer, Take A Hike!’ program promotes sun safety and skin cancer awareness
July 15, 2018 - Blink Health announces lowest prices for generic prescriptions through Blue Eagle Health
July 15, 2018 - New drug strategy can alleviate multiple behavioral, cellular deficiencies in FXS mouse model
July 15, 2018 - Georgia State professor receives federal grant to study virus similar to Ebola virus
July 15, 2018 - Quitting Smoking? Even a Little Exercise Can Help You Stay Slim
July 15, 2018 - DBS treatment may slow the progression of Parkinson’s tremor in early-stage patients
July 15, 2018 - 5 Questions: Luby on virus with potential to cause global pandemic | News Center
July 15, 2018 - Corn loses its cancer-fighting phenolic acids when processed into cornflakes
July 15, 2018 - Study uncovers possible link between iron loading, alcohol intake and mortality
July 15, 2018 - Molecular insights of NagA enzyme could help combat TB
FDA Approves Auryxia (ferric Citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis

FDA Approves Auryxia (ferric Citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis

image_pdfDownload PDFimage_print

BOSTON, Nov. 07, 2017 (GLOBE NEWSWIRE) — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on bringing innovative medicines to people with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD), not on dialysis. Auryxia was originally approved in September 2014 for the control of serum phosphorus levels in people with chronic kidney disease who require dialysis.

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 Medicare Part D and commercial insurance providers in the United States.

“More than half of the approximate 30 million people in the United States living with chronic kidney disease are iron deficient, and yet, this is the only tablet that has been developed and approved specifically to address iron deficiency anemia in these patients, who are not on dialysis,” said Steven Fishbane, M.D., chief, division of kidney diseases and hypertension, department of medicine, Northwell Health in Great Neck, New York. “Starting today, physicians can prescribe an oral iron medicine to help people living with this condition, the majority of whom are not being optimally treated.”

“We are pleased with the broad indication permitted by the FDA, as a first-line treatment option for adults with iron deficiency anemia and chronic kidney disease, not on dialysis,” said John Neylan, M.D., senior vice president and chief medical officer of Keryx Biopharmaceuticals. “Physicians and their patients now have a new treatment option to help manage a serious complication of this complex disease.”

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 January 2017 in the online issue of the Journal of the American Society of Nephrology (JASN).

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

Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis and approved on November 6, 2017 for the treatment of iron deficiency anemia in adults 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.

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 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.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, Inc., with headquarters 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.

References

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

Source: Keryx Biopharmaceuticals, Inc.

Posted: November 2017

Related Articles:

Auryxia (ferric citrate) FDA Approval History

Tagged with:

About author

Related Articles