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news.The European Commission has granted marketing authorisation in the European Union (EU) for Vifor Pharma's Velphoro (sucroferric oxyhydroxide) to treat hyperphosphatemia in adult patients with Chronic Kidney Disease (CKD) on haemodialysis or peritoneal dialysis.
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Velphoro, a non-calcium, iron-based, chewable phosphate binder, was issued a positive opinion in June 2014 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation of the product.
The marketing authorisation of Velphoro in Europe for the 28 EU countries was based on data from a Phase III trial which met its primary and secondary endpoints.
The trail showed the drug successfully controls hyperphosphatemia with fewer pills compared to sevelamer carbonate, which is the current standard of care in patients with CKD on dialysis.
Vifor Pharma the developer of Velphoro transferred all rights in 2011 to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care.
In November 2013, the company secured approval for Velphoro from the US Food and Drug Administration (FDA) for the control of serum phosphorus levels in patients with CKD on dialysis.
In the US, Velphoro was launched by Fresenius Medical Care North America in March 2014.
Vifor Pharma, a company of the Galenica Group, also provides a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products.