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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/6676/2016

EMEA/H/C/002733

EPAR summary for the public

Feraccru

ferric maltol

This is a summary of the European public assessment report (EPAR) for Feraccru. 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 Feraccru.

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

What is Feraccru and what is it used for?

Feraccru is an iron-containing medicine. It is used to treat anaemia (low levels of red blood cells or haemoglobin) caused by a lack of iron (iron deficiency) in adults with inflammatory conditions of the gut known as 'inflammatory bowel disease' (such as ulcerative colitis and Crohn's disease).

Feraccru contains the active substance ferric maltol.

How is Feraccru used?

Feraccru is available as capsules (30 mg). The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach. Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.

The medicine can only be obtained with a prescription.

How does Feraccru work?

Iron deficiency anaemia is a common problem in patients with inflammatory bowel disease. It is caused by various factors including bleeding and poor absorption of iron from food in the inflamed gut of these patients.

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The active substance in Feraccru, ferric maltol, is an iron-containing compound. When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels. As iron is an essential building block for haemoglobin, the body can produce more haemoglobin and correct the anaemia once iron stores are replenished.

What benefits of Feraccru have been shown in studies?

Feraccru was compared with placebo (a dummy treatment) in one main study involving 128 patients with inflammatory bowel disease who had iron deficiency anaemia, defined as haemoglobin levels below 12.0 grams per decilitre (g/dl). The main measure of effectiveness was how much haemoglobin levels rose after 12 weeks of treatment.

Feraccru was more effective than placebo at increasing haemoglobin levels: in patients taking Feraccru, haemoglobin levels increased on average from 11.0 to 13.2 g/dl whereas in patients given placebo they remained around 11.1 g/dl. In addition, around 65% of patients given Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.

What are the risks associated with Feraccru?

The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity. Severe side effects include abdominal pain, constipation and diarrhoea. For the full list of all side effects reported with Feraccru, see the package leaflet.

Feraccru must not be used in patients with iron overload disorder (haemachromatosis) or in patients receiving repeated blood transfusions. For the full list of restrictions, see the package leaflet.

Why is Feraccru approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Feraccru's benefits are greater than its risks and recommended that it be approved for use in the EU. Feraccru has been shown to be effective in increasing haemoglobin levels in patients with inflammatory bowel disease and iron deficiency anaemia. The safety profile of Feraccru is considered acceptable, with side effects which are mostly mild to moderate in intensity and in line with those of other iron preparations.

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

A risk management plan has been developed to ensure that Feraccru 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 Feraccru, 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 Feraccru

The European Commission granted a marketing authorisation valid throughout the European Union for Feraccru on 18 February 2016.

Feraccru

EMA/6676/2016    Page 2/3

The full EPAR and risk management plan summary for Feraccru 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 Feraccru, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2016.

Feraccru

EMA/6676/2016