CHMP Backs Ferric Maltol for Iron Deficiency Anemia in IBD

Megan Brooks


December 18, 2015

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval ferric maltol (Feraccru, Iron Therapeutics UK Ltd) for the treatment of iron deficiency anemia in adults with inflammatory bowel disease (IBD).

Ferric maltol is an oral trivalent iron preparation that provides iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body (transferrin and ferritin, respectively). The benefits with Feraccru are its ability to increase hemoglobin levels in patients, the European Medicines Agency notes in a news release.

The most common adverse effects are abdominal pain (including in the upper abdomen), flatulence, constipation, abdominal discomfort/distension, diarrhea, and nausea.

Feraccru should be prescribed by physicians experienced in the treatment of iron deficiency anemia, the CHMP advised. Once approved, Feraccru will be available as 30-mg hard capsules.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.


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