Velphoro® receives Swissmedic approval for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis
Tuesday, 27 January 2015, ↓ directly to download
Velphoro® is a non-calcium, iron-based, chewable phosphate binder. Approval has already been given in the 28 EU member states and the USA, based on study data showing that Velphoro® can control hyperphosphatemia with fewer tablets than sevelamer carbonate, the current standard of care in patients with CKD on dialysis1. After 24 weeks, the average daily dose required to control hyperphosphatemia was only 3.1 tablets for Velphoro®, compared to 8.1 tablets with sevelamer carbonate.
Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis. Most are treated with a phosphate binder, however 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 behind this3,4. On average, dialysis patients take approximately 19 pills per day, with phosphate binders5 comprising around 50% of this daily pill burden.
The recommended starting dose of Velphoro® is 3 tablets per day (1 tablet per meal), so Velphoro® can contribute to improving phosphate management in these patients. Velphoro® will be available in Switzerland by end of March 2015.
Velphoro® was developed by Vifor Pharma and is produced in Switzerland. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care. Velphoro® is distributed in Switzerland by Vifor Pharma.
Further information can be found at www.velphoro.ch.
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 markets innovative and high-quality treatments aimed at improving the lives of patients around the world with chronic kidney disease (CKD). The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.
Velphoro® is a non-calcium, iron-based, chewable phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches. When taken with meals, Velphoro® adsorbs the dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood. The absorbed phosphate is subsequently eliminated through the faeces.
1. Floege J et al., Efficacy and safety of a novel iron-based phosphate binder in dialysis patients, in a Phase III study. Kidney Int 2014;86(3):638-47.
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 2014;29(11):2092-9.
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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