Vifor Pharma has obtained EU marketing authorisation from the European Commission for its Velphoro (sucroferric oxyhydroxide) to treat hyperphosphatemia in adult CKD patients on dialysis.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorisation for Velphoro in June.
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Vifor, along with Fresenius Medical Care, has developed Velphoro. It is a non-calcium, iron-based and chewable phosphate binder, which contains mixture of polynuclear iron (III) oxyhydroxide, sucrose and starches.
The authorisation for the 28 EU countries was based on a Phase III study, which Velphoro reached primary and secondary endpoints in.
The study showed that Velphoro has controlled hyperphosphatemia more efficiently with fewer pills, compared with sevelamer carbonate, the current standard of care in patients with CKD on dialysis.
In 2011, Vifor Pharma transferred all rights related to Velphoro to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care.
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By GlobalDataIn November 2013, the US Food and Drug Administration (FDA) granted approval for Velphoro to control serum phosphorus levels in patients with CKD on dialysis.
Fresenius Medical Care North America has launched the product in US in March.
Based in Zurich, Switzerland, Vifor Pharma, develops, manufactures and markets pharmaceutical products to treat iron deficiency.
