BRIEF—FDA approves Injectafer for heart failure patients with iron deficiency

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Injectafer (ferric carboxymaltose injection), Japanese drugmaker Daiichi Sankyo and its US subsidiary, American Regent, have announced.

With this approval, Injectafer is now the first and only intravenous (IV) iron replacement approved to treat iron deficiency in adult patients with heart failure (HF) categorized as New York Heart Association class II/III to improve exercise capacity.

Around 6.2 million US adults are living with heart failure - a progressive and chronic disease - and nearly half (45%) have iron deficiency/iron deficiency anemia that can impact their daily lives.

The regulatory decision is supported by data that demonstrated Injectafer’s ability to improve exercise capacity in heart failure patients with iron deficiency.