Daiichi Sankyo and American Regent Announce Approval of INJECTAFER® A
Monday, June 05, 2023
Daiichi Sankyo and American Regent have jointly announced the approval of INJECTAFER® (ferric carboxymaltose injection) by the U.S. Food and Drug Administration (FDA).
This approval grants the usage of INJECTAFER® for treating iron deficiency in adult patients with heart failure who are categorised as New York Heart Association class II/III, with the aim of enhancing their exercise capacity.
INJECTAFER is now the first and only indicated intravenous (IV) iron replacement therapy for iron-deficient adult heart failure patients.
INJECTAFER, known for being the extensively researched intravenous iron option, has further reinforced its track record with this recent approval. It continues to demonstrate its efficacy and reliability in the treatment of iron deficiency anaemia for both adult and paediatric patients.
Now, with the approval for adult patients with heart failure who also suffer from iron deficiency, INJECTAFER expands its range of application.
The approval of INJECTAFER was backed by compelling data derived from a randomised controlled study called CONFIRM-HF (NCT01453608). The findings from the study demonstrated that treatment with INJECTAFER exhibited a significant improvement in exercise capacity when compared to a placebo, specifically in iron-deficient patients with heart failure.
