New York: On 5^th June,2023 Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced US-FDA approval for its INJECTAFER (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure. INJECTAFER is found to be efficient in increasing exercise tolerance in adult patients with heart failure classified as New York Heart Association class II/III and treat iron deficiency. The New York Heart Association Functional Classification is referred by healthcare professionals to classify a patient’s heart failure based on the severity of the symptoms. Patients having slight or marked limitation of their physical activity due to fatigue, palpitation or dyspnea are categorized as class II or Class three heart failure.

The approval was supported by INJECTAFER data from a randomized controlled study- CONFIRM-HF (NCT01453608), which evaluated the efficacy and safety of ferric carboxymaltose in several patients suffering chronic heart failure and iron deficiency. The treatment with INJECTAFER resulted in significantly improved exercise capacity in comparison to placebo in iron deficient patient with heart failure. Over 8,800 patients from all over the world participated in more than 40 research clinical trials conducted for studying INJECTAFER. The iron injection remained well tolerated among the individuals who received it and demonstrated an acceptable safety profile.

INJECTAFER is indicated for the treatment of iron deficiency in adult patients with heart failure and iron deficiency anemia (IDA) in adults and pediatric patients (above 1 yr) who are either intolerant to oral iron or have an inadequate response to oral iron, as well as patients having non-dialysis dependent chronic renal disease. The dosage of INJECTAFER in patients for heart failure and New York Heart Association class II/III is designed based on the patient weight (154.3 lbs.) and hemoglobin level (ranges from <10 to 14-15 grams per deciliter (g/dl), set up at a single 500 mg dose up to two 1000 mg doses separated by six weeks).Also some patients may receive a maintenance dose of 500 mg every 12 , 24 and 36 weeks depending on their blood ferritin levels and transferrin saturation value.

INJECTAFER is the only most extensively researched IV iron, having received approval in 86 countries since its initial European Union approval in 2007. Some of the mild to moderate and transient adverse effects of INJECTAFER include nausea, hypertension, headache, injection site reactions, hypophosphatemia, and dizziness.

According to the Chief Medical Officer, at American Regent, ““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,”. “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.”

According to TechSci Research, INJECTAFER’seffectiveness and benefits in heart failure patients have positioned it as a preferred choice among healthcare providers, leading to increased demand and expanding market opportunities for American Regent. Also, being the first ever FDA approved Intravenous iron replacement therapy, this first-mover advantage can create a significant competitive edge for the company. The approval from the U.S. Food and Drug Administration (FDA) validates the safety, efficacy, and quality of INJECTAFER, instilling confidence in healthcare providers, patients, and stakeholders. With FDA approval, more healthcare facilities and providers are likely to adopt INJECTAFER as a standard treatment option, expanding its usage and market reach.

Prevalence of heart failure has been steadily rising, creating a significant patient population that can benefit from intravenous iron therapy. With heart failure often accompanied by iron deficiency, INJECTAFER plays a crucial role in addressing this coexisting condition and improving patient outcomes. As healthcare providers recognize the importance of managing iron deficiency in heart failure patients, the demand for intravenous iron treatments like INJECTAFER has increased in the healthcare market.

Moreover, FDA approval plays a crucial role in securing reimbursement from insurance providers and government healthcare programs therefore, with FDA approval, healthcare providers could seek reimbursement for the treatment via INJECTAFER, making it more accessible and affordable for patients. Additionally, the broader implications of improved patient outcomes and reduced hospitalizations result in cost savings for healthcare systems and payers. Furthermore, FDA approval for INJECTAFER opens doors for further research and development opportunities. It encourages manufacturers, including American Regent, to invest in additional studies to explore new indications, expanded patient populations, or improved formulations. These research endeavors not only advance medical knowledge but also drive innovation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets stimulating growth and propelling the healthcare market growth.