Keryx Biopharmaceuticals (NASDAQ:KERX) reported that a leading Medicare Part D plan financier has included Auryxia to its list of formularies, effective next month. The U.S. FDA approved Auryxia in 2014 and is indicated in the country for the control of serum phosphorus levels in people with CKD on dialysis.
This approval from the U.S. FDA was based on report from the firm’s Phase III registration program in people with dialysis. In the Phase III trials, Auryxia lowered serum phosphorus levels within the established set range of 3.5 to 5.5 mg/dL.
The highlights
Keryx reported that Auryxia binds closely with dietary phosphate in the GI region and advances as ferric phosphate. The uncontrolled part of Auryxia has been demonstrated to increase serum iron limits including ferritin and TSAT. Iron absorption may result in excessive rise in quantity of iron stores. Accordingly, physicians should evaluate and monitor iron elements before commencing and while on Auryxia, and may require to discontinue or decrease IV iron for these people.
The common grave events for Auryxia cured people were gastrointestinal related, counting nausea, vomiting, constipation and diarrhea. Use of ferric citrate in people with IDA and NDD-CKD, as mentioned above, is untried and has not been stated to be efficacious or safe.
Keryx has also mentioned certain safety information for Auryxia. People with iron overload indication, such as hemochromatosis, should not be administered Auryxia®. There may be iron absorption, which may result in increased iron in storage sites. Therefore, iron parameters should be tracked before and while on Auryxia. People receiving IV iron may need discontinuation or a reduction in dose of IV iron treatment.
Accidental overdose of iron comprising products is a top cause of fatal poisoning in kids aged below 6 years. Auryxia should be kept away from kids as it contains iron. Safety has not been proven for people suffering with gastrointestinal bleeding.