EU Commission approves Velphoro for treatment of Hyperphosphatemia in CKD patients - Vifor Fresenius Renal Pharma

Velphoro (sucroferric oxyhydroxide) from Vifor Fresenius Renal Pharma has received EU marketing authorisation from the European Commission for the control of serum phosphorus levels in adult patients with Chronic Kidney Disease (CKD) on haemodialysis or peritoneal dialysis. In June, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for the product.

Velphoro is a non-calcium, iron-based, chewable phosphate binder. The EU marketing authorisation for the 28 EU countries 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.