Drugs Xagena
Velphoro ( Sucroferric oxyhydroxide ) has been approved by FDA ( Food and Drug Administration ) for the control of serum phosphorus levels in patients with chronic kidney disease ( CKD ) on dialysis.
Velphoro ( previously known as PA21 ) is an iron-based, calcium-free, chewable phosphate binder.
US approval was based on a pivotal Phase III study, which met its primary and secondary endpoints. The study demonstrated that Velphoro successfully controls hyperphosphatemia with fewer pills than Sevelamer carbonate, the current standard of care in patients with CKD on dialysis. The average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.
Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis.
Most dialysis patients are treated with phosphate binders. However, despite the availability of a number of different phosphate binders, up to 50% of patients, depending on the region, are still unable to achieve and maintain their target serum phosphorus levels.
In some patients, non-compliance due to the high pill burden and poor tolerability appear to be key factors in the lack of control of serum phosphorus levels. On average, dialysis patients take approximately 19 pills per day with phosphate binders comprising approximately 50% of the total daily pill burden.
The recommended starting dose of Velphoro is 3 tablets per day ( 1 tablet per meal ).
Full results from the pivotal Phase III study involving more than 1,000 patients were presented at both the 50th ERA-EDTA ( European Renal Association - European Dialysis and Transplant Association ) Congress in Istanbul, Turkey, in May 2013, and the American Society of Nephrology ( ASN ) Kidney Week in Atlanta, Georgia, in November 2013. ( Xagena )
Source: Vifor Pharma, 2013
XagenaMedicine_2013
