Velphoro® receives EU marketing authorisation for treatment of hyperphosphatemia in adult CKD patients on dialysis
Wednesday, 27 August 2014, ↓ directly to download
Velphoro® (sucroferric oxyhydroxide) has received EU marketing authorisation from the European Commission for the control of serum phosphorus levels in adult patients with Chronic Kidney Disease (CKD) on haemodialysis or peritoneal dialysis. In June, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for the product.
Velphoro® is a non-calcium, iron-based, chewable phosphate binder. The EU marketing authorisation for the 28 EU countries was based on a pivotal Phase III study which met its primary and secondary endpoints. The study demonstrated that Velphoro® successfully controls hyperphosphatemia with fewer pills than sevelamer carbonate, the current standard of care in patients with CKD on dialysis1. The average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.
Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis. Most dialysis patients are treated with phosphate binders, but up to 50% of patients – depending on the region – are unable to achieve and maintain their target serum phosphorus levels2. In some patients, non-compliance due to the high pill burden and poor tolerability appear to be key factors in the lack of control of serum phosphorus levels3,4. On average, dialysis patients take approximately 19 pills per day with phosphate binders5 comprising approximately 50% of the total daily pill burden. The recommended starting dose of Velphoro® is three tablets per day (one tablet per meal), and Velphoro® could therefore help to improve phosphate management and improve outcomes in patients who currently do not comply with treatment due to the high pill burden.
Velphoro® was developed by Vifor Pharma, which produces the active ingredient in Switzerland. All rights were transferred in 2011 to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care. Velphoro® was approved by the US Food and Drug Administration (FDA) for the control of serum phosphorus levels in patients with CKD on dialysis in November 2013 and launched in the US by Fresenius Medical Care North America in March 2014.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Galenica and Fresenius Medical Care develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.
Velphoro® (previously known as PA21) is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron (III)-oxyhydroxide, sucrose and starches. Each tablet of Velphoro® contains the equivalent of 500mg of iron. When taken with meals, Velphoro® adsorbs the dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood. The adsorbed phosphate is subsequently eliminated through the faeces.
The Velphoro® Phase II clinical trial met both its primary and secondary endpoints. The serum phosphorus lowering efficacy of the two lowest active doses was numerically comparable to 4.8g/day sevelamer hydrochloride. Velphoro® was also well tolerated, with a comparable overall safety and tolerability profile.
The Phase III trial was an open-label, randomised, active controlled, parallel group study to investigate the safety and efficacy of Velphoro® compared to sevelamer carbonate, followed by a randomized comparison of Velphoro® maintenance dose versus Velphoro® inactive low-dose in dialysis patients with hyperphosphatemia.
Velphoro® is developed in collaboration with Fresenius Medical Care (www.fmc-ag.com). It is also currently undergoing Phase III clinical development in Japan by Kissei Pharmaceutical Co., Ltd.
1. Floege J et al. Efficacy and safety of an iron-based phosphate binder, PA21, in hyperphosphatemic CKD patients on dialysis; Poster SA-PO1103, ASN congress 2012, San Diego.
2. US-DOPPS Practice Monitor, October 2013; http://www.dopps.org/DPM/
3. Tonelli M, et al. Oral Phosphate Binders in Patients with Kidney Failure; NEJM 2010;362:1312–1324.
4. Wang S et al. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis; Nephrol Dial Transplant 2013 Sep 5. [Epub ahead of print]
5. Chiu YW, et al. Pill Burden, Adherence, Hyperphosphatemia, and Quality of Life in Maintenance Dialysis Patients; Clin J Am Soc Nephrol 2009;4(6):1089–1096.
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