Vifor's Velphoro gains marketing authorization in the EU for hyperphosphatemia

Switzerland-based iron deficiency specialist Vifor has received European Union marketing authorization for its Velphoro (sucroferric oxyhydroxide). This non-calcium, iron-based, chewable phosphate binder controls serum phosphorus levels in adult patients with chronic kidney disease on hemodialysis or peritoneal dialysis.

The authorization was based on a Phase III study meeting its primary and secondary endpoints, showing that Velphoro successfully controls hyperphosphatemia with fewer pills than the current standard, sevelamer carbonate. Hyperphosphatemia (an abnormal elevation of phosphorus levels in the blood) is a common condition in chronic kidney disease patients on dialysis, which can be serious. Dialysis patients take an average of 19 pills per day, and phosphate binders comprise around 50% of that. The recommended starting dose of Velphoro is three tablets per day, and could therefore help to improve phosphate management for patients who do not currently comply with treatment due to the high pill burden.

The US Food and Drug Administration approved Velphoro for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis last Year (The Pharma Letter November 28, 2013).