Feraccru® (ferric maltol) Launched in the UK for the Treatment of Adults with Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease

LONDON, June 17, 2016 /PRNewswire/ --

Latest oral iron treatment is effective with a safety profile comparable to placebo in patients who have failed oral ferrous treatments
 

Shield Therapeutics PLC announced today that Feraccru® (ferric maltol) is now available in the UK as a treatment for adults with iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD) who have previously failed on oral iron (ferrous) products. An estimated 300,000 people in the UK have IBD.^[1] IDA is the most common non-intestinal symptom of the disease and affects from 36-76% of patients.^[2] The British Society of Gastroenterology guidelines recommend iron supplementation to correct IDA and replenish iron stores in all patients.^[3]

The symptoms of IDA in IBD (e.g. fatigue) can have a significant impact on patients' activities of daily living, including their ability to work.^[4] Feraccru, a novel and effective oral ferric iron treatment for IDA, provides a new oral ferric alternative for adult IBD patients with IDA who have failed oral ferrous products and is a well-tolerated oral alternative to intravenous (IV) iron in mild-moderate IBD patients.^[5],[6] Feraccru addresses an unmet need in IBD care as tolerance and adherence issues restrict the viability of oral ferrous treatments.^[6]

'‘There is a real unmet need for a well-tolerated oral iron replacement for IBD patients with IDA who have failed oral ferrous products. Oral ferrous treatments aren't well tolerated and patients often don't adhere to treatment; this limits their efficacy. The availability of Feraccru is an important step in helping to fulfil this unmet need and may help reduce the need to progress to IV iron treatments," commented Dr Tariq Iqbal, Consultant Gastroenterologist, Queen Elizabeth hospital, Birmingham, UK. "IV iron works very well in IBD but there are issues about capacity, especially as these patients are also on infused biologic therapy. We have a 6-week waiting list for IV iron and Feraccru provides another potential option for treating these patients quickly and efficiently."

Data from the company's prospective, randomised, placebo controlled "AEGIS" clinical programme of adult patients with IDA secondary to IBD and for whom treatment with oral ferrous products was unsuccessful, showed Feraccru to be an effective and well tolerated treatment comparable to a placebo. Statistically significant improvements in haemoglobin (Hb) were identified, after 12 weeks of treatment with oral Feraccru (30 mg twice a day) [2.25 (0.19) g/dL (p < 0.0001).^[6] Throughout the 64-week study period, median compliance to the prescribed therapeutic regimen was 97%.^[7]

Shield Founder and Chief Executive Officer, Carl Sterritt, added, "As part of our ongoing commitment to improve the lives of IDA patients with IBD, we are very pleased to report that they now have access to Feraccru in the UK.  Based on the highly compelling results generated throughout its clinical trials we believe that Feraccru is an exciting new oral treatment option for patients who have failed on oral ferrous products. These patients may previously have had to progress to IV iron or might have received no treatment at all. We would like to thank all the people who took part in our clinical trials, the investigators and everyone involved in bringing this important product to the market."

For the UK Summary of Product Characteristics for Feraccru please visit: https://www.medicines.org.uk/emc/medicine/31722

Notes to editors  

About iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD)  

Crohn's Disease and Ulcerative Colitis are the two main forms of IBD, affecting more than 300,000 people in the UK.^[1] Anaemia is a common complication of IBD, with IDA being the most prevalent cause affecting from 36-76% of patients.^[2]

The impact of IDA on the quality of life (QoL) of IBD patients is substantial. It affects various aspects of QoL such as physical, emotional, and cognitive functions, the ability to work, hospitalisation, and healthcare costs. The symptoms of IDA in IBD (e.g. fatigue) can have a significant impact on patients' activities of daily living, including their ability to work.^[8] QoL for patients improves with correction of anaemia, and this improvement is independent of IBD clinical activity.^[9]-[10]

About Feraccru 

Feraccru is a novel and effective oral ferric iron treatment for IDA in IBD. Data from the "AEGIS" clinical programme which included 128 adult patients showed statistically significant improvements in haemoglobin (Hb) vs. placebo, after 12 weeks of treatment with oral Feraccru (30 mg twice a day) [2.25 (0.19) g/dL (p < 0.0001).^[6] Hb improvements [3.07 ±1.46 g/dL] continued to be seen throughout the open-label safety phase, which followed patients for up to 64 weeks.^[7] Normalisation of Hb was achieved in two-thirds of patients after 12 weeks of treatment and in >80% of patients who continued treatment for up to 64 weeks. The safety profile of Feraccru was comparable to placebo at 12 weeks^[6] and well tolerated in treatment up to 64 weeks^[7], with 74% of entered patients completing the long-term phase.^[7] Throughout the 64-week study period, median compliance to the prescribed therapeutic regimen was 97%.^[7]

About Shield Therapeutics 

Shield Therapeutics PLC (http://www.shieldtherapeutics.com ), founded in 2008, is a UK based specialty pharmaceutical company focused on the development and commercialisation of late-stage, hospital-focused pharmaceuticals which address areas of high unmet medical need.

References      

1. Crohn's and colitis UK - Accessed June 1st 2016 

2. Stein J, Hartmann F, Dignass AU. Diagnosis and management of iron deficiency anemia in patients with IBD. Nat Rev Gastroenterol Hepatol. 2010;7(11):599-610 

3. Goddard AF, et al. Guidelines for the management of iron deficiency anaemia. Gut 2011;60:1309-1316. 

4. Danese S, et al. Eur J Gastroenterol Hepatol 2014;26:1385-1391 

5. Feraccru. Summary of Product Characteristics. Shield. February 2016 

6. Gasche et al. Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program. Inflamm Bowel Dis, 21, 579 - 588 (2015) 

7. Schmidt, C., Ahmad, T., Tulassay, Z., et al. (2015). Long-term treatment with ferric maltol is effective and well tolerated in correcting iron deficiency anaemia in patients with inflammatory bowel disease: open-label extension data from a Phase 3 double-blind, placebo-controlled trial programme. Alimentary Pharmacology and Therapeutics 2016 

8. 12 Ershler WB, Chen K, Reyes EB, Dubois R. Economic burden of patients with anemia in selected diseases. Value Health 2005;8:629-38 

9. Wells CW, Lewis S, Barton JR, Corbett S. Effects of changes in haemoglobin level on quality of life and cognitive function in inflammatory bowel disease patients. Inflamm Bowel Dis 2006;12:123-30 

10 Evstatiev R, Marteau P, Iqbal T, et al. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology 2011;141:846-53, e841-42 

For more information about Shield Therapeutics, please contact: 

Kimberly Santiago, Liberation Unlimited
Tel. +44(0)7711-484-267
E-mail: ksantiago@liberationunlimited.com