The US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis.
Approval of Velphor, which is an iron-based, calcium-free, chewable phosphate binder, was based on Phase III trial, which met its primary and secondary endpoints.
The trial showed that Velphoro controls hyperphosphatemia with fewer pills than sevelamer carbonate, the current standard of care in patients with CKD on dialysis and the average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.
In the US, Fresenius Medical Care North America will be responsible for marketing the hyperphosphatemia drug from 2014.
The active ingredient of Velphoro (previously known as PA21) is produced by Vifor Pharma in Switzerland.
Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis and most dialysis patients are treated with phosphate binders.
According to the company, despite the availability of several different phosphate binders, about 50% of patients are still unable to achieve and maintain their target serum phosphorus levels.
In some patients, non-compliance due to the high pill burden and poor tolerability seems to be major factor in the lack of control of serum phosphorus levels.
On an average, dialysis patients take about 19 pills per day with phosphate binders including about 50% of the total daily pill burden.
Currently, regulatory processes of Velphoro are being carried out in Europe, Switzerland and Singapore with decisions expected in the first half 2014, while further submissions for approval are being prepared.
