This article is more than 5 years old. Information may no longer be current.
FDA approves new phosphate binder Velphoro for dialysis patients
Click Here to Manage Email Alerts
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.
(Phosphate-binding drug does not improve heart health of patients with mild kidney disease)
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.
(New chewing gum designed to reduce phosphate levels in chronic kidney disease patients)
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.
Find more articles about Renal Nutrition