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Pro-Trader Daily: Corporate News Blog - Keryx Announces FDA Approval of Auryxia for Treatment of Iron Deficiency Anemia Patients with Chronic Kidney Disease

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LONDON, UK / ACCESSWIRE / November 9, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) ("Keryx"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=KERX. The Company announced on November 07, 2017, that the US Food and Drug Administration (FDA) has approved Auryxia® (Ferric Citrate) Tablets ("Auryxia") for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD), and not on dialysis. Keryx is a Company focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney diseases. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Array BioPharma Inc. (NASDAQ: ARRY) for due-diligence and potential coverage as the Company announced on October 31, 2017, its financial results for Q1 FY18 and also provided an update on the progress of its key clinical development programs. Tune in to our site to register for a free membership, and be among the early birds that get our report on Array BioPharma when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on KERX; also brushing on ARRY. Go directly to your stock of interest and access today's free coverage at:

http://protraderdaily.com/optin/'symbol=KERX

http://protraderdaily.com/optin/'symbol=ARRY

Current Statistics for Iron Deficiency Anemia

  • CKD is widespread in the US, affecting one out of every seven adults. Of that, more than half are estimated to have iron deficiency anemia.
  • Iron is a very important mineral required for the normal functioning of the human body. It is a critical component of the human blood as it is needed to make healthy red blood cells. Thus, a lack of iron leads to anemia as sufficient hemoglobin is not produced in the body.
  • Moreover, iron deficiency anemia has serious negative implications on patients' quality of life because it could also lead to cardiovascular complications and increased mortality risk.
  • The severity of iron deficiency anemia increases as kidney disease progresses.
  • It is estimated that every year, nephrologists treat around 650,000 people for iron deficiency anemia who have CKD and are not on dialysis.
  • In fact, it is estimated that around 250,000 to 400,000 patients currently under the care of a nephrologist have CKD and iron deficiency anemia but are not treated.

About Auryxia® (Ferric Citrate) Tablets

  • As of now, Auryxia is the only oral treatment approved option available specifically for adults living with iron deficiency anemia and CKD, not on dialysis.
  • On September 05, 2014, the FDA approved Auryxia for the control of serum phosphorus levels in adults with CKD on dialysis. And then, on November 06, 2017, it was approved for the treatment of iron deficiency anemia in adults with CKD not on dialysis.
  • Auryxia tablets contain around 210 mg of ferric iron, which is equal 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 (i.e. two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (i.e. one per meal).

Approval Based on Phase-3 Clinical Trial Results

The supplemental new drug application (sNDA) of Auryxia was approved on the basis of the results from its Phase-3 clinical trial.

Study Design

  • The Phase-3 clinical trial was a 24-week placebo-controlled clinical trial in 234 adults with stage 3-5 non-dialysis dependent CKD.
  • People with hemoglobin level in the range of 9.0 g/dL to 11.5 g/dL, and who were intolerant to, or had an inadequate response to prior treatment with, oral iron supplements were enrolled for the trial.
  • For the trial, the starting dose was three tablets per day taken with meals and the mean dose was five tablets per day.
  • Patients were not permitted to receive any intravenous (IV), or oral iron, or erythropoiesis-stimulating agents (ESAs) during the study.

Results

  • Treatment with Auryxia exhibited significant improvements in hemoglobin levels of >1 g/dL at any point during the 16-week efficacy period for majority of patients (52.1%, n=61/117 compared to 19.1%, n=22/115 in the placebo group), which is a clinically meaningful result.
  • Besides, it was mostly well tolerated and adverse events were consistent with its known safety profile.
  • The most commonly reported adverse events in the trial were diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%), and hyperkalemia (7%).

Only Oral Treatment Option for People with Iron Deficiency Anemia

The FDA's approval of Auryxia for treatment of people with iron deficiency anemia and CKD, not on dialysis, would benefit millions of people living with this condition. Currently, this medication is available in pharmacies and covered broadly by Medicare Part D and commercial insurance providers in the United States.

Steven Fishbane, M.D., Chief, Division of Kidney Diseases and Hypertension, Department of Medicine, Northwell Health in Great Neck, New York, shared his views about Auryxia's new indication. He stated that approximately half of the 30 million people living with CKD in the US are iron deficient. But still, Auryxia is the only oral treatment option that has been specifically developed and approved for addressing iron deficiency anemia in these patients, who are not on dialysis. And thanks to the FDA's approval, physicians can now prescribe an oral iron medicine to help people living with this condition, the majority of whom are not being optimally treated.

Similarly, John Neylan, M.D., Senior Vice President and Chief Medical Officer of Keryx, expressed his pleasure on Auryxia's broad indication approved by the FDA, as a first-line treatment option for adults with iron deficiency anemia and CKD, not on dialysis.

Last Close Stock Review

Keryx Biopharma's share price finished yesterday's trading session at $5.08, sliding 1.36%. A total volume of 4.93 million shares have exchanged hands, which was higher than the 3-month average volume of 1.53 million shares. The Company's stock price advanced 6.05% in the previous twelve months. The stock currently has a market cap of $544.53 million.

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PRO-TD has not been compensated; directly or indirectly; for producing or publishing this document.

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The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email contact@protraderdaily.com. Rohit Tuli, a CFA® charter-holder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by PRO-TD. PRO-TD is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

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SOURCE: Pro-Trader Daily

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