Keryx, Upcoming PDUFA Action on Label Expansion for Auryxia - Erie News Now | WICU & WSEE in Erie, PA

Keryx, Upcoming PDUFA Action on Label Expansion for Auryxia

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NEW YORK, NY / ACCESSWIRE / October 5, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies, is issuing a comprehensive report with no obligation on Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), a commercial-stage company focused on bringing innovative medicines to people with renal disease.

The company is poised for a Label Expansion Opportunity. A supplemental new drug application seeking approval of Auryxia for the treatment of patients with iron deficiency anemia and non-dialysis dependent chronic kidney disease is currently under FDA review.

Currently, there is no FDA approved oral treatment to treat iron deficiency in non-dialysis-dependent chronic kidney disease.

Get the details of the upcoming PDUFA action for Auryxia here: READ MORE.

Copy and paste to your browser may be required to view the report – http://tradersnewssource.com/keryx/.

Auryxia has already presented encouraging results in a pivotal Phase 3 trial where it showed statistically significant differences over placebo for the primary and secondary endpoints and potential FDA approval could help in expanding the addressable market for the drug as it will then be able to cover the NDD market, which consists of patients who are not yet required to be put on dialysis, or the stage which is referred to as End Stage Kidney Disease (ESKD).

Iron deficiency anemia is a severe disease and, today, as many as three out of four people with chronic kidney disease, and iron deficiency anemia, are not being optimally treated with existing iron supplements.

Get the KERX guidance for 2017, the outlook for Auryxia, and financial review here: READ MORE.

Copy and paste to your browser may be required to view the report – http://tradersnewssource.com/keryx/.

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