ST. GALLEN, SWITZERLAND, March 19, 2024 /PRNewswire/ -- CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III* ¹ to improve exercise capacity.² Ferinject has now received marketing authorization in 87 countries worldwide.

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age³ and children⁴.

"While iron deficiency and associated anemia are some of the most prevalent medical conditions on a global scale, it is easily diagnosed and treatable," said Prof. Dr. Justin Ezekowitz, Director of Cardiovascular Research and Cardiologist at the University of Alberta, Canada. "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."

Iron deficiency affects one in every two hospitalized patients with heart failure⁵. Iron deficiency is often accompanied by reduced exercise tolerance and untreated iron deficiency may result in anemia and worsening NYHA class, with reduced quality of life and eventually increased risk of hospitalization ^6,7,8

"The approval by Health Canada marks an important step forward for the treatment of iron deficiency anemia as well as iron deficiency in heart failure and supports our promise to patients and public health," said Dr. Vinicius Gomes de Lima, Head of Global Medical Affairs, CSL Vifor. "We are confident that our now approved IV iron therapy can make a meaningful contribution to achieve key therapeutic goals in the treatment of these patients."

Marketing authorization in Canada is based on a comprehensive clinical data package and totality of evidence from CSL Vifor's cardiology studies. In Canada, Ferinject^® is commercialized through CSL Behring Canada, Inc., with availability expected in the second half of 2024.

* The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.⁹

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).

The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor, visit www.cslvifor.com.

About Ferinject

Ferinject (ferric carboxymaltose) is an IV iron therapy with marketing authorization in 87 countries as of March 2024. Ferinject has historically delivered significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure¹⁰.

In Canada, Ferinject is indicated for the treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and NYHA class II/III to improve exercise capacity. The diagnosis of iron deficiency must be based on laboratory tests.²

Important Information for Canada

For more information and a complete risk/benefit profile, please refer to the Product Monograph available here.

About iron deficiency and associated anemia

Iron plays a vital role in many bodily processes, including the production of red blood cells, effective heart and brain function, and the prevention of infection and illness. Without enough iron, the body is unable to function properly. Common symptoms include fatigue, dizziness, and shortness of breath. Iron deficiency and iron deficiency anemia are estimated to affect one in three people worldwide¹¹, yet despite the serious consequences and high prevalence¹², the conditions remain under-recognized.

The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being¹³. Iron deficiency and iron deficiency anemia can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality¹³. Common symptoms include fatigue ^13,14,15 pale skin¹⁴, brittle nails^{14, 16}, craving non-food items such as dirt, clay and ice¹⁷, and an inability to concentrate^{13, 18}. In children, iron deficiency anemia can significantly impair cognitive and motor development^19,20,21.

Multiple organizations, including the World Health Organization (WHO), UNICEF and the U.S. Agency for International Development (USAID) have called for a comprehensive anemia monitoring framework. Find more information on the global burden of anemia in the report published in the Lancet in July 2023: https://pubmed.ncbi.nlm.nih.gov/37536353/.

References

1. Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9^th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.
2. Ferinject Product Monograph. CSL Vifor, St. Gallen, Switzerland.
3. Chang V et al. J Nutr 2022 ; 153 : 781-797. doi.org/10.1016/j.tjnut.2022.10.011; Cochrane K et al. J Nutr 2022;152:2238-2244.
4. Tahir E et al. 2020 Can J Public Health 111, 682-693 (2020). doi.org/10.17269/s41997-020-00304-7; Abdullah K et al Canadian Paediatric Surveillance program, 2011 www.cpsp.cps.ca/uploads/publications/RA-iron-deficiency-anemia.pdf.
5. Del Pinto et al. Eur Heart J Suppl. 2022 Nov; 24(Suppl I): I96-I99).
6. Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013;5(9):3730-9. doi:10.3390/nu5093730.
7. Klip IT, Comin-Colet J, Voors A a, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013;165(4):575-582.e3. doi:10.1016/j.ahj.2013.01.017.
8. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268-275.
9. Classes of Heart Failure. American Heart Association. May 2017. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure
10. Data on file. PSUR report. CSL Vifor, St. Gallen, Switzerland.
11. Peyrin-Biroulet L, et al. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94.
12. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: http://apps.who.int/iris/bitstream/handle/10665/43894/9789241596657_eng.pdf;jsessionid=9C613E2F4D481EDEB9DE07986AFC E0C7?sequence=1. Last accessed: November 2023.
13. Fernando B, et al. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive diseases. World J Gastroenterol. 2009 Oct 7; 15(37): 4638-4643.
14. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38.
15. Favrat, B., et al. (2014). Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One 9(4): e94217. eCollection 2014.
16. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5.
17. Barton JC, et al. Pica associated with iron deficiency or depletion: clinical and laboratory correlates in 262 non-pregnant adult outpatients. BMC Blood Disord. 2010;10:9. doi:10.1186/1471-2326-10-9.
18. Patterson A et al. Iron deficiency, general health and fatigue: Results from the Australian Longitudinal Study on Women's Health. Qual Life Res. 2000;9:491-497.
19. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: http://www.who.int/nutrition/publications/micronutrients/anaemias-tools-prevention-control/en/. Last accessed: November 2023.
20. Sant-Rayn S, et al. Diagnosis and management of iron deficiency anaemia: a clinical update. Med J Aust 2010; 193 (9): 525-532. doi: 10.5694/j.1326-5377.2010.tb04038.x.
21. Özdemir N. Iron deficiency anemia from diagnosis to treatment in children. Turk Pediatri Ars. 2015 Mar 1;50(1):11-9. doi: 10.5152/tpa.2015.2337. PMID: 26078692; PMCID: PMC4462328.

CSL Vifor Media Contact
Thomas Hutter

+41 79 957 96 73
media@viforpharma.com

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