FDA approves first IV iron replacement therapy for heart failure
Key takeaways:
- The FDA approved the first and only IV iron replacement therapy indicated for people with heart failure and iron deficiency.
- The therapy was previously approved for patients with iron deficiency anemia.
The FDA approved the first IV ferric carboxymaltose injection for iron deficiency in adults with heart failure to improve exercise capacity, according to a press release from American Regent.
The IV iron injection (Injectafer, Daiichi Sankyo/American Regent) is approved for people with New York Heart Association class II/III HF, defined as patients with a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea.
“This new indication for Injectafer marks the first and only FDA approval of an IV iron replacement therapy for adult patients with HF, a progressive and chronic disease,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in the release. “Approximately 2.8 million U.S. adults are impacted by HF with iron deficiency or iron deficiency anemia, which can affect their daily lives and activities. Injectafer is the most extensively studied IV iron and this latest approval continues to build on the effective and proven use of Injectafer for adult and pediatric patients with iron deficiency anemia, and now for adult patients with HF who have iron deficiency.”
The approval was supported by data from a randomized controlled study, CONFIRM-HF, that evaluated the efficacy and safety of IV ferric carboxymaltose in adult patients with chronic HF and iron deficiency. Treatment with IV ferric carboxymaltose significantly improved exercise capacity compared with placebo in iron-deficient patients with HF.
The safety results from the trial were generally consistent with the known safety profile of Injectafer. The most common treatment emergent adverse events observed with Injectafer were headache, nausea, hypertension, injection site reactions, hypophosphatemia and dizziness.
Injectafer has been approved in 86 countries since initial European Union approval in 2007 and is the most extensively studied IV iron, according to the release.
Collapse
Press Release