FDA Approves Velphoro
On November 27, the FDA approved Velphoro (PA21; sucroferric oxyhydroxide) for the treatment of hyperphosphataemia in chronic kidney disease patients on dialysis. The product, owned by Vifor Fresenius Medical Care Renal Pharma France, will be launched by Fresenius Medical Care North America in 2014.
Velphoro is a chewable, iron-based phosphate binder. Each tablet contains the equivalent of 500mg of iron. When taken with meals, Velphoro adsorbs the dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood. The adsorbed phosphate is subsequently eliminated through the faeces.
Velphoro was developed by Vifor Pharma, which transferred all rights for the product to Vifor Fresenius Medical Care Renal Pharma in 2011. Velphoro is also currently undergoing Phase III development in Japan by Kissei Pharmaceuticals.