CSL Vifor’s Injectafer (ferric carboxymaltose) has been approved in the US for improvement in exercise capacity in adults with symptomatic heart failure (HF) who have iron deficiency. Injectafer’s approval means it is the first and only intravenous (IV) iron replacement therapy in the US indicated for this particular patient population. Consequently, Injectafer is not expected to be in direct competition with other classes of drugs, as it will be used in combination with other drugs for the management of HF. A significant number of chronic HF patients suffer from iron deficiency and these patients are either not diagnosed or do not receive adequate treatment for iron deficiency. Injectafer’s approval allows potentially iron-deficient patients to better manage their symptomatic HF.
Key opinion leaders interviewed by GlobalData have emphasised that iron replacement therapy can be helpful, but these therapies represent a niche market in the HF space. Injectafer’s FDA approval was supported by the CONFIRM-HF Phase IV trial. The trial demonstrated that over a year of treatment with ferric carboxymaltose resulted in significant and sustainable improvement in exercise capacity in adults with symptomatic HF. In addition, the safety profiles were consistent with the well-established safety profile of the medicine.
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Anaemia is prevalent among cohorts of patients with HF. The prevalence of anaemia in HF patients ranges from 9% to 70% of patients. The presence of anaemia in this patient population is associated with recurrent hospitalisation and reduced survival.
Ferric carboxymaltose rapidly improves haemoglobin levels and replenishes depleted iron stores. In terms of iron therapies, Injectafer will continue penetrating the IV iron therapy market. The drug maintained its blockbuster status in 2021. CSL Vifor granted American Regent Inc, a subsidiary of Daiichi Sankyo, an exclusive right to develop, manufacture, and market Injectafer in the US.
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