o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/390444/2014

EMEA/H/C/002705

EPAR summary for the public

Velphoro

sucroferric oxyhydroxide

This is a summary of the European public assessment report (EPAR) for Velphoro. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Velphoro.

For practical information about using Velphoro, patients should read the package leaflet or contact their doctor or pharmacist.

What is Velphoro and what is it used for?

Velphoro is a medicine used to control blood-phosphate levels in adults with long-term kidney disease who are undergoing haemodialysis or peritoneal dialysis to remove waste products from the blood.

Velphoro is 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.

The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).

How is Velphoro used?

Velphoro is available as chewable tablets (containing 500 mg of iron). The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals. The dose of Velphoro should be adjusted every two to four weeks, until an acceptable level of phosphate in the blood is reached, which should then be monitored regularly. The maximum dose is 3,000 mg (6 tablets) per day.

Patients should keep to their prescribed low-phosphate diets. The tablets must be chewed and not swallowed whole.

The medicine can only be obtained with a prescription.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

How does Velphoro work?

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, 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.

What benefits of Velphoro have been shown in studies?

Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia. All patients were on dialysis and received either Velphoro or another phosphate binder, sevelamer, for 6 months. After 6 months, more than half of the patients could then continue on the same treatment for up to one year, while a small group received Velphoro at a lower dose for three weeks only. The study looked at the change in the amount of phosphate in the blood, measured in units of mmol/L.

Velphoro was as effective as sevelamer in reducing patients' blood-phosphate levels and maintaining this effect. After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer. In patients whose dose of Velphoro was then lowered, phosphate levels increased after 3 weeks, whereas the levels remained stable in those who continued treatment on the same dose for up to one year.

What are the risks associated with Velphoro?

The most common side effects with Velphoro (which may affect more than 1 in 10 people) are diarrhoea and discoloured faeces, which may become less frequent with continued treatment.

Velphoro must not be used in patients with iron accumulation disorders such as haemochromatosis.

For the full list of all side effects and restrictions with Velphoro, see the package leaflet.

Why is Velphoro approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels. There were no major safety concerns and although tolerability is slightly lower than with sevelamer, the overall safety profile was acceptable. The risk of excess iron build-up was considered limited but should be followed up after approval.

What measures are being taken to ensure the safe and effective use of Velphoro?

A risk management plan has been developed to ensure that Velphoro is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velphoro, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Velphoro

The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.

The full EPAR and risk management plan summary for Velphoro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Velphoro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2014.

Velphoro

EMA/390444/2014

Page 3/3