Shield Therapeutics (Shield), an independent pharmaceutical company focused on the development of specialist hospital pharmaceuticals, today announces the recent acceptance for review by the European Medicines Agency (EMA) of the Marketing Authorisation Application (MAA) for Feraccru (ST10, ferric maltol). Shield is seeking marketing authorisation of Feraccru for the treatment of iron deficiency anaemia (IDA), initially in patients with inflammatory bowel disease (IBD) and those intolerant of oral ferrous therapies, thereby providing an effective alternative to those patients whose only current option is intravenous iron therapy.
The MAA for Feraccru, a novel orally-delivered form of ferric iron, is based on the highly positive findings of the AEGIS pivotal Phase III programme. Data from this study showed that Feraccru delivered a mean increase in haemoglobin levels of 2.3g/dL in 12 weeks, clearly meeting the primary endpoint of haemoglobin change compared to placebo (p<0.0001). Feraccru also rapidly delivered significant haemoglobin increases after only 4 weeks of therapy (1.1g/dL, p<0.0001) and more than 65% of treated subjects experienced normalised haemoglobin levels by week 12.
These results strongly demonstrated Feraccru’s potential to be the only realistic oral treatment for ferrous intolerant IDA patients, thereby providing an effective alternative therapy to i.v. iron, which comes with the risk of serious and life-threatening hypersensitivity reactions. Leading regulatory agencies such as the EMA specify1 that i.v. irons only be administered when full resuscitation facilities can be assured, suitably trained staff are immediately available and patients are closely observed following each injection. Together these requirements significantly complicate administration of such therapies.
The EMA will review the application under the centralised marketing authorisation procedure. When approved Feraccru will receive marketing authorisation in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.
Feraccru is also being studied for the treatment of IDA in pre-dialysis chronic kidney disease patients and the data generated from this study will, along with the data generated from the pivotal studies in IBD patients, be used to form part of a subsequent New Drug Application submission to the FDA in the USA.
Effectiveness data on Feraccru were presented in 2014 at ECCO and UEGW, will soon be published in a leading peer-reviewed journal and will be further presented at the ECCO meeting in February 2015.
Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical University of Vienna, Austria, the Principal Investigator on the AEGIS Phase III Programme, said:
“The results of the AEGIS study confirm our belief that Feraccru has real potential to become a leading treatment of iron deficiency anaemia. Not only did the results show a significant increase in haemoglobin levels, but it was also very well tolerated in our patients. Once approved we would expect Feraccru to provide a simple and effective alternative to intravenous iron for our patients.