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Health Canada Grants Approval for Ferinject® to Treat Iron Deficiency Anemia in Adult and Pediatric Patients, Along with Iron Deficiency in Adult Patients with Heart Failure

Wednesday, March 20, 2024

CSL Vifor has announced that Ferinject (ferric carboxymaltose) has received authorization from Health Canada for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients aged one year and older, when oral iron preparations are ineffective or not tolerated. Additionally, it is approved for treating iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to enhance exercise capacity. This authorization expands Ferinject's reach to 87 countries worldwide.

Recent research indicates that iron deficiency rates in Canada are higher than previously reported, particularly among women of reproductive age and children.

Prof. Dr. Justin Ezekowitz, Director of Cardiovascular Research at the University of Alberta, Canada, emphasized the significance of this approval, stating that oral iron treatments may not always yield desired outcomes for Canadian patients with heart failure affected by iron deficiency.

Iron deficiency affects half of hospitalized heart failure patients, often leading to reduced exercise tolerance and potentially worsening symptoms. Untreated, it can progress to anemia, worsening NYHA class, and increased hospitalization risk.

Dr. Vinicius Gomes de Lima, Head of Global Medical Affairs at CSL Vifor, expressed confidence in Ferinject's ability to address these patient needs and contribute positively to treatment outcomes.

The approval by Health Canada is backed by extensive clinical data from CSL Vifor's cardiology studies. Ferinject will be available in Canada through CSL Behring Canada, Inc., expected in the latter half of 2024.

Ferinject is an intravenous iron therapy with a proven track record of efficacy and safety, having been authorized in 87 countries. It has demonstrated significant value to patients and healthcare systems over its extensive use.

In Canada, Ferinject is indicated for treating iron deficiency anemia in both adults and pediatric patients when oral iron preparations fail, as well as for managing iron deficiency in adult heart failure patients with NYHA class II/III to enhance exercise capacity. Diagnosis must be based on laboratory tests.

Iron deficiency and associated anemia can have serious consequences, impacting general health and quality of life. Recognizing the symptoms and promptly addressing iron deficiency is crucial to preventing complications and improving patient outcomes.

Iron deficiency remains under-recognized despite its high prevalence worldwide. It can lead to debilitating symptoms and exacerbate underlying chronic conditions, emphasizing the importance of effective treatment options like Ferinject.



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