The U.S. Food and Drug Administration has approved Velphoro (sucroferric oxyhydroxide) to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro, developed by the Swiss company Vifor Pharma and transferred to Vifor Fresenius Medical Care Renal Pharma, will be marketed by Fresenius Medical Care North America in 2014.
Velphoro, previously known as PA2, is an iron-based, calcium-free, chewable phosphate binder. U.S. approval was based on a pivotal Phase III study that 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.
Vifor Fresenius Medical Care Renal Pharma chief executive Charles DeLoach told PharmaTimes that the company had asked a Swiss university to do tests so that to get the right balance between having enough pliability to keep the tablet intact, yet keep it soft enough so that it can be chewed easily, a problem for many dialysis patients.