The US Food and Drug Administration (FDA) has approved sucroferric oxyhydroxide (Velphoro, Vifor Fresenius Medical Care Renal Pharma) for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) who are receiving dialysis, according to a company news release.
Sucroferric oxyhydroxide is an iron-based, calcium-free, chewable phosphate binder.
The FDA approval was based on results of a phase 3 study involving more than 1000 patients presented earlier this year at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 50th Congress in Istanbul, Turkey.
As reported by Medscape Medical News, the study showed that Velphoro (formerly PA21) controls hyperphosphatemia over the long term and has a lower pill burden than sevelamer carbonate, the current standard of care in patients with CKD who are receiving dialysis.
Hyperphosphatemia is a common problem in patients with CKD who are receiving dialysis. Most dialysis patients are treated with phosphate binders, but many do not achieve and maintain target serum phosphorus levels, the company notes in the news release.
"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 levels. On average, dialysis patients take approximately 19 pills per day with phosphate binders comprising approximately 50% of the total daily pill burden," they point out.
In the phase 3 study, the average daily dose of Velphoro needed to control hyperphosphatemia was 3.3 pills per day after 52 weeks. The recommended starting dose is 3 tablets per day (1 tablet per meal).
Velphoro will be launched in the United States by Fresenius Medical Care North America in 2014, the company said.
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Cite this: FDA Clears New Phosphate Binder Velphoro - Medscape - Dec 03, 2013.
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