Reading, UK, 23rd July 2014: TranScrip Partners LLP were pleased to support Vifor Pharma with gaining EU approval for Velphoro®, a novel, iron-based phosphate binder, for the treatment of hyperphosphataemia in patients with chronic kidney disease (CKD), on dialysis.
The detailed press information from Vifor Pharma can be found at http://www.viforpharma.com/en/Media/mediareleases/2014/20140626_8603057854-recommendation-velphoro.php.
Velphoro® (sucroferric oxyhydroxide) has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending marketing authorisation for the control of serum phosphorus levels in adult patients with CKD on haemodialysis or peritoneal dialysis. The final decision on the approval by the European Commission is expected in autumn 2014. This approval follows on from the earlier FDA approval in November 2013, for which TranScrip also provided submission support.
Ursula Mason, Senior Partner at TranScrip and Project Director for Vifor said “TranScrip have been a long standing clinical/regulatory partner to Vifor and we are delighted to see the latest successful approval.”