Velphoro receives US FDA approval for hyperphosphatemia in CKD

Switzerland-based Vifor Pharma, part of the Galenica group (SIX: GALN), has received US Food and Drug Administration (FDA) approval for Velphoro (sucroferric oxyhydroxide) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

A New Drug Application for Velphoro, previously known as PA21 (iron(III)-oxyhydroxide), was submitted in February. US approval 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.

Lowers pill burden for patients