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news.Galenica and its US partner Luitpold Pharmaceuticals have reported the data from large, multi-center, randomised, controlled clinical trials, which evaluated the efficacy and cardiovascular risk profile of Injectafer.
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Injectafer (US brand name of Ferinject) is a non-dextran intravenous iron replacement therapy comprising Ferric carboxymaltose as the active pharmaceutical ingredient.
The first trial compared Injectafer to either oral or intravenous (iv) iron (standard of care therapy) in patients with iron deficiency anaemia of various etiologies.
The second trial, comprising 2,561 patients, compared Injectafer to Venofer (iron sucrose injection) where two 750 mg doses of Injectafer raised hemoglobin more than five 200 mg doses of Venofer.
The trials met their efficacy and safety endpoints.
The mean change in hemoglobin was higher for Injectafer in both trials and the rates of the composite cardiovascular safety endpoint was statistically similar for Injectafer versus oral iron or i.v. standard of care.