EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis.
Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood phosphate levels), which, in the long term, can cause complications such as heart and bone disease.
The active substance in Velphoro, sucroferric oxyhydroxide, a mixture of iron (III)-oxyhydroxide, sucrose and starches, is a phosphate binder. When taken with meals, the iron contained in Velphoro attaches to phosphate from food within the gut, preventing it from being absorbed into the body and helping to keep down the phosphate levels in the blood.
Velphoro should be used with other treatments such as calcium or vitamin-D supplements, which help to control bone disease linked to kidney failure and high phosphate levels.
Velphoro in the new therapeutic indication brings a significant clinical benefit compared to existing treatments. There are currently no existing therapies of phosphate binders indicated for the control of serum phosphorus levels in children between 2 and 6 years old with CKD stages 4-5 who are not on dialysis. In addition, the medicine has been re-formulated into 125 mg powder for oral suspension, which is easier to be administered to small children.
The adverse reactions most frequently reported with this treatment were gastrointestinal disorders, including diarrhoea, vomiting, gastritis and discoloured faeces.
- The marketing authorisation holder is Vifor Fresenius Medical Care Renal Pharma France.
- Velphoro is currently approved as 500 mg chewable tablets for use in adults only.
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