Feraccru®

(ferric maltol)

 

Feraccru®
Feraccru® is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies. When salt-based oral iron therapies are ingested, the iron must dissociate from the salt in the GI tract to allow the iron to be absorbed and treat the IDA. This free iron readily chelates to form insoluble clumps and produces damaging free radicals that together cause a range of mild-to-severe GI adverse events, including nausea, bloating and constipation, leading to poor tolerability, reduced patient compliance and ultimately treatment failure. In addition, many patients with IDA are concurrently treated with medicines that raise the pH in the gut which further reduces the effect of salt-based oral iron therapies as they require highly acidic conditions to be absorbed. Feraccru® is not an iron salt, and iron can be absorbed from the ferric maltol molecule, as a result, it does not routinely cause the same treatment-limiting intolerance issues. Feraccru® has been shown in clinical trials to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.

Currently, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru®. IV iron therapies, however, are invasive, costly, inconvenient and complex to administer, and also come with potentially life-threatening, spontaneous hypersensitivity reactions.

Other Feraccru® pipeline events:

Feraccru® in Europe – possible extension of commercial label
In September 2017, Shield submitted an application to the European Medicines Agency, to broaden the existing commercial label for Feraccru® to include the treatment of all patients with ID, which has the potential to significantly expand the market opportunity for Feraccru® in Europe. We continue to expect a final decision from the EMA on this application during the first half of 2018.

Feraccru® AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru® to the market-leading latest generation form of IV iron (Ferinject/Injectafer, ferric carboxymaltose).  Primary endpoint data from the AEGIS-H2H study is expected to be available in the second half of 2018.

Patient Information

Indication
Feraccru® is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). The medicine can only be obtained with a prescription.

For further information on Ferracru® please click below:

If you experience any side effects with Feraccru®, talk to your doctor or nurse. This includes any side effects not listed in the patient information leaflet. You can also report side effects directly via your country national reporting system. http://www.adrreports.eu/en/national.html.

By reporting side effects, you can help provide more information on the safety of Feraccru®. Always read the patient information leaflet provided with your medicine.

If you have a question or complaint about our products, or have experienced a side effect, please contact us.

London, UK

120 New Cavendish Street
London
W1W 6XX

t+44 (0) 207 186 8500

einfo@shieldtx.com

Newcastle, UK

Northern Design Centre
Baltic Business Quarter
Gateshead Quays, NE8 3DF

t+44 (0) 191 511 8500

einfo@shieldtx.com

Wollerau, Switzerland

Sihleggstrasse 23,
8832 Wollerau
Switzerland

t+41 (0) 435 080 781

einfo@shieldtx.com

Munich, Germany

München 5 Höfe
Theatinerstrasse 11
DE- 80333 München

t+49 (0) 89 710 42 2246

einfo.de@shieldtx.com