Galenica’s US partner Luitpold Pharmaceuticals has submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer, used to treat iron deficiency anaemia.
Injectafer is a non-dextran intravenous iron (i.v.) replacement therapy containing ferric carboxymaltose as its active pharmaceutical ingredient.
The submission includes the data from two randomised controlled clinical trials which assessed the cardiovascular risk profile of Injectafer.
One trial compares Injectafer to Venofer (iron sucrose injection) in patients with iron deficiency anaemia and chronic kidney disease, while the second study compares Injectafer to either oral or intravenous (i.v.) iron in patients with iron deficiency anaemia of various etiologies.