CSL-VIFOR

Regulatory News:

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CSL Vifor and Fresenius Kabi today announced that China’s National Medical Products Administration (NMPA) has approved Ferinject^®, a preparation for intravenous iron therapy for the treatment of iron deficiency in adult patients for whom oral iron preparations are ineffective, oral iron preparations cannot be used or for whom there is a clinical need to deliver iron rapidly. Ferinject^® has now received marketing authorization in 85 countries worldwide.

“We are thrilled about the marketing authorization of Ferinject^®, which is a milestone for Chinese patients living with iron deficiency or iron deficiency anemia”, said Hervé Gisserot, General Manager of CSL Vifor. “There is a high unmet need in China, which has the world’s largest iron deficiency population, and we are confident that Ferinject^® can make a meaningful difference in the treatment of these patients. At the same time, this is another important step in our goal to globalizing and maximizing the performance of our iron franchise as we look forward to bring this treatment to market as soon as possible.”

“Marketing authorization of Ferinject^® will strengthen our commitment of bringing innovative medicines for patients in China. We are guided by our corporate philosophy of caring for life and invested to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face”, said Yang Weiping, President of Fresenius Kabi China.

The approval of Ferinject^® may also enable a more effective implementation of PBM in Chinese hospitals, where an estimated 3-4 million patients undergo elective surgery each year. In China, PBM encompasses multiple in-hospital procedures across therapeutic areas. The China National Health Commission (NHC) has announced guidelines for perioperative PBM as a health standard across China, effective as per 1 June 2022.

Marketing authorization in China is based on positive clinical results from the phase-III trial VIT-IRON-2011-004. This open label, randomized multicenter study showed that Ferinject^® is an effective and well-tolerated alternative to iron sucrose for the treatment of iron deficiency anemia that can provide an improved hemoglobin response and correction of iron deficiency in Chinese patients.

CSL Vifor and Fresenius Kabi currently expect to begin to market Ferinject^® in the first half of 2023, with National Reimbursement Drug List (NRDL) listing anticipated in January 2024.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. 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 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com.

About Fresenius Kabi

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

With its corporate mission of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face. For more information, please visit www.fresenius-kabi.com.

About Ferinject^®

Ferinject^®/Injectafer^® (ferric carboxymaltose) is an i.v. iron therapy with market authorization in 85 countries by November 2022. More than 19 million patient years of experience have helped to establish Ferinject^®/ Injectafer^® as a trusted brand, with clinical benefits demonstrated by its efficacy and safety data². Ferinject’s^® quality relies on a consistent and firmly-controlled manufacturing process based on decades of experience.

About iron deficiency

Iron Deficiency affects about half of the patients with chronic kidney disease³ and chronic heart failure and is associated with reduced quality of life⁴, an increased risk of hospitalization⁵ and cardiovascular death⁶. Despite the serious consequences and high prevalence, of iron deficiency, the condition remains under-recognized⁷.

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 is estimated to affect one in three people worldwide⁸, yet despite the serious consequences and high prevalence⁹, it remains an under-recognized condition.

Although iron deficiency can affect anyone, it is most prevalent in premenopausal women, pregnant woman and children under five¹⁰. Left untreated, it can develop into iron deficiency anemia. The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being¹¹. Even without anemia, iron deficiency can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality¹². Common symptoms include fatigue^{11, 13, 14} pale skin¹³, brittle nails^{13, 15}, craving non-food items such as dirt, clay and ice¹⁶, and an inability to concentrate^{11, 17}. In children, iron deficiency can significantly impair cognitive and motor development¹⁸.

About Patient Blood Management (PBM)

PBM is designed to improve surgical and medical patient outcomes by optimally managing and preserving patients’ blood. Proactive identification and treatment of iron deficiency anemia in patients scheduled for elective surgery has been associated with a reduced need for blood transfusion¹⁹ , reduced length of hospital stay¹⁹, improved patient’s outcomes²⁰, and overall healthcare expenditure reduction²¹.

References:

1. Ni W, Yuan X, Sun Y, et al. Anaemia and associated factors among older adults in an urban district in China: a large-scale crosssectional study. BMJ Open 2022;12:e056100. doi:10.1136/ bmjopen-2021-056100.

2. Scott Drugs. 2018 Mar;78(4):479–493. doi: 10.1007/ s40265-018-0885-7.

3. Wong MMY et al. Clin Kid J 2019:1–12; Rocha BML, et al. J Am Coll Cardiol. 2018;71(7):782–793.

4. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268–275.

5. Guedes et al. J Am Soc Nephrol. 2021 Aug;32(8):2020-2030, Martens P, et al. Acta Cardiol. 2018;73(2):115–123.

6. Guedes et al. J Am Soc Nephrol. 2021 Aug;32(8):2020-2030; Klip IT, et al. Am Heart J. 2013;165:575–82.e3.

7. Eur J Heart Fail. 2021 Sep 3. doi: 10.1002/ejhf.2338.

8. 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.

9. 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=9C613E2F4D481EDEB9DE07986AFCE0C7?sequence=1. Last accessed: June 2018.

10. Hercberg S, et al. Iron deficiency in Europe. Public Health Nutr. 2007;4(2b).

11. 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.

12. Cappellini MD et al. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078.

13. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38.

14. 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.

15. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5.

16. 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.

17. 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.

18. 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: June 2018.

19. Froessler B. et al., Ann Surg 2016

20. Kotzé A. et al., British Journal of Anaesthesia 2012

21. Basora M. et al., Blood Transfus 2018

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