Keryx FDA Approval For Expanded Indication To Move The Needle – Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) –

Keryx FDA Approval For Expanded Indication To Move The Needle – Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX)


On Tuesday, Keryx Biopharmaceuticals (KERX) introduced that the FDA had accepted Auryxia for a further indication. The expanded approval is for the remedy of iron deficiency anemia in adults with power kidney illness (CKD) not on dialysis. I really feel that this can be a good win for the corporate, not simply because it obtained accepted by the FDA. The new indication is predicted to permit for tens of millions of extra CKD sufferers that may now be handled with Auryxia. This drug was initially accepted again in 2014 to manage of serum phosphorus ranges in sufferers with power kidney illness who require dialysis. In my opinion, this new expanded indication might be a recreation changer for the corporate.

Phase three Data

The sNDA of Auryxia was doable on account of optimistic information that was noticed in a part three medical trial. The trial recruited a complete of 234 grownup CKD sufferers who weren’t depending on dialysis. These sufferers had been between stage three to stage 5 CKD. Patients within the trial had been both handled with Auryxia (ferric citrate) or a placebo. The major endpoint of the trial was to look at a 1g/dL or larger rise in hemoglobin ranges at any time level through the 16 weeks of efficacy statement interval. The major endpoint was met as 52% of the sufferers had met the objective of the examine whereas taking Auryxia, whereas solely 19% of the sufferers met the objective within the placebo group. This gave a statistically important p-value of p < zero.001. What I really like about this information isn’t just for the truth that this examine met on the first endpoint. It additionally was as a result of the drug Auryxia was safer to take in comparison with the placebo. In the examine it was famous that two sufferers within the placebo group had discontinued the examine. There had been no dropouts within the remedy group and that is a crucial facet to think about. The commonest antagonistic occasion with remedy of Auryxia was diarrhea. Although, for my part, that may be simply resolved with OTC drugs.

Market Opportunity

It is estimated that there are at the least 1.6 million folks dwelling within the United States alone with stage three to stage 5 non-dialysis dependent CKD. It was crucial for Keryx to obtain FDA approval for this indication. That’s as a result of it’s the solely FDA accepted iron remedy for these sufferers that’s in a pill type. Other iron substitute therapies should be given intravenously, and for my part oral pill types of remedy are far superior due to affected person compliance.


According to the 10-Q SEC submitting, Keryx has money and money equivalents of $114 million as of September 30, 2017. The enhance in proceeds of money was due to inventory sale agreements that had been made again in December 6, 2016. The firm believes that its present money available, together with the inventory sale agreements in place, ought to be sufficient to fund operations in the meanwhile. Sales of Auryxia for the three months ending September 30, 2017, had been $13.6 million. That’s in comparison with the $5.1 million that was produced in the identical time interval in 2016.


The greatest threat could be whether or not or not Auryxia can carry out higher over different CKD iron remedies. It appears that the drug has been doing fairly properly for CKD dialysis dependent sufferers. Therefore, I imagine that Auryxia will do properly in CKD non-dialysis dependent sufferers. This is as a result of the brand new expanded indication opens up Keryx to a bigger market alternative in comparison with the primary indication. Especially, when you think about that there are tens of millions of extra sufferers that the corporate can now go after.


The FDA approval for the expanded indication of Auryxia ought to badist Keryx enhance upon its gross sales figures. The new market alternative will possible lead to a lift for the corporate and its shareholders. The part three information reported by the corporate proves simply how properly the drug works in non-dialysis dependent sufferers with CKD. I imagine that with this new indication Keryx is a superb long-term funding.

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