FDA Approves Velphoro for Treatment of Hyperphosphatemia in Kidney Disease Patients on Dialysis
Launch expected in 2014 (November 28)
Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care) has received FDA approval for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The drug is an iron-based, calcium-free, chewable phosphate binder.
The FDA’s approval was based on data from a pivotal phase III study, which met its primary and secondary endpoints. The study demonstrated that the drug successfully controls hyperphosphatemia with fewer pills than sevelamer carbonate (Renvela, Sanofi-Aventis), 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 is a common condition in CKD patients on dialysis. Most dialysis patients are treated with phosphate binders. However, despite the availability of a number of different binders, up to 50% of patients are still unable to achieve and maintain their target serum phosphorus levels.
Results from the pivotal phase III study of Velphoro, which involved more than 1,000 patients, were presented at the American Society of Nephrology (ASN) Kidney Week in Atlanta, Georgia, in November 2013.
The U.S. launch is expected in 2014.
Source: Vifor Pharma; November 28, 2013.