Oral iron replacement therapy Feraccru has been shown to have comparable efficacy to intravenously delivered Ferinject in patients with Iron Deficiency Anaemia.
Shield Therapeutics and Norgine announced the positive results, which they say showed that Ferracru demonstrated increases in the mean Hb levels comparable to those achieved with IV FCM.
Patients with IDA, whose Inflammatory Bowel Disease (IBD) is inactive, now have an important alternative treatment option, which is both effective over the long term and well tolerated, therefore reducing the need for time-consuming and expensive hospital administration, the firms noted.
Current oral iron treatments can be poorly tolerated and don’t always work, which leads to many unwell patients having to receive IV iron in hospital.
“The results of this study provide an important opportunity to change clinical practice to improve patients’ lives. Patients with inactive Inflammatory Bowel Disease who are unwell as a result of Iron Deficiency Anaemia have often tried a number of oral iron treatments which didn’t work or they couldn’t tolerate,” commented Dr Alastair Benbow, chief medical and development officer at Norgine.
“Previously, they would have needed to go to hospital for time-consuming and expensive IV administration. Now many patients can be treated at home with an effective and well-tolerated oral iron alternative” he added.
The 52 week trial consisted of 242 patients across the USA and Europe with haemoglobin measurements as low as 8.0g/dL. The study analysed the efficacy of Feraccru against Ferinject in a 12 week treatment, and was followed by a 40-week extension phase, during which the subjects continued with the doses.
Norgine has an exclusive licence agreement with Shield for commercialisation of the product in Europe, Australia and New Zealand.