European Regulators Approve Vifor Fresenius’ Velphoro
Europe’s regulatory body, the European Commission, has approved Vifor Fresenius Medical Care Renal Pharma’s hyperphosphatemia drug Velphoro.
The regulatory approval for Velphoro, formerly known as PA21, was centered on results from a Phase III clinical trial, which showed that Velphoro successfully controls the accumulation of phosphorus in the blood.
The drug also presents a much lower pill burden than the current standard of care in patients with chronic kidney disease on dialysis.
Dialysis patients currently take an average of 19 pills per day with 50% of the pills being phosphate binders. In contrast, the recommended starting dose of Velphoro is three tablets per day.
Velphoro was originally developed by Vifor Pharma. In 2011, all rights for the drug were transferred to Vifor Fresenius Medical Care Renal Pharma. Velphoro was previously granted regulatory approval in the USA in November 2013, and was launched earlier this year.