EMA Committee Recommends Expanded Indication Approval For Vifor Fresenius Medicals Velphoro To Treat Children With CKD

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.Vifor Fresenius Medical Care Renal Pharma France is the marketing authorisation holder of Velphoro. Velphoro is currently approved as 500 mg chewable tablets for use in adults only.The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.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.EMA’s human medicines committee (CHMP) based its recommendation for Velphoro on the assessment of an open-label, randomised phase 3 clinical study, which included 85 children from 2 years of age with CKD and hyperphosphatemia. The results showed normal phosphorus range after treatment in a large proportion of patients, comparable to what was observed for adults.The adverse reactions most frequently reported with this treatment were gastrointestinal disorders, including diarrhoea, vomiting, gastritis and discoloured faeces.Following the CHMP recommendation, the summary of product characteristics, the package leaflet and the labelling for Velphoro will be updated accordingly.

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