FDA Approves Auryxia Tablets, Keryx Biopharmaceuticals (NASDAQ:KERX) Announces

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Keryx Biopharmaceuticals (NASDAQ:KERX), one of the Top Biotech Stocks, is a biopharmaceutical provider dedicated to serving patients with renal complication with innovative medicines. The leading biopharmaceutical company has today made public its joy after the U.S. Food and Drug Administration took take time to review its supplemental New Drug Application. It is a drug application for Auryxia® (ferric citrate) tablets which is raising hopes high among patients. The step by FDA was a great one since it has now given room for sNDA to be reviewed.

Auryxia is at the moment already approved and patients in the U.S can now freely use it for the purpose of regulating serum phosphorus levels among those patients undergoing the end-stage renal disease needing dialysis. Keryx, through its sNDA submission seeks to expand the indication for Auryxia in such a manner that it will be able to cater for the treatment of iron deficiency anemia (IDA) in persons displaying the non-dialysis dependent chronic kidney disease.

One thing that is for sure is the fact that Iron deficiency anemia happens to be a common phenomenon in persons exhibiting the non-dialysis dependent chronic kidney disease. At this particular moment, there doesn’t seem to be any of the FDA-approved oral medicines to deal with the debilitating condition. The senior vice president and chief medical officer of Keryx Biopharmaceuticals, John Neylan has stated that the acceptance of the sNDA filing asides from taking them a step closer towards the provision of the medicine to the needy persons, it is also quite a huge milestone for the high end provider in its efforts to power ferric citrate’s mechanism of action.

The sNDA was a construct from a 24-week placebo regulated Phase 3 trial in 234 adults suffering from the 3-5 NDD-CKD. The patients involved in the study had their hemoglobin standing at levels of 9.0 g/dL and 11.5 g/dL. They showcased intolerance and also were attributed with inadequate responses to prior treatments using the various oral supplements. At the start, patients were served with three tablets daily and had to make sure they had taken their meals before taking the drugs.

The various studies taking place globally will go a long way towards helping ensure wellness for patients. It is a good thing that most of the Best Biotech Stocks are getting involved in seeking top solutions for patients around the globe.


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