A comprehensive understanding of the socio-demographic, clinical, and biological characteristics of patients with heart failure is essential to develop novel strategies for improving outcomes. The identification of the barriers to guideline-directed medical therapy implementation in a real-world setting is critical to decreasing the risk of heart failure hospitalization and mortality. A comprehensive and well-designed heart failure registry can determine the clinical characteristics of patients with heart failure, identify patient, physician, and healthcare system-related factors for the non-use of evidence-based therapies, and improve the implementation of guideline-directed medical therapy. It should be noted that the number of heart failure registries that enroll patients with de novo heart failure, chronic heart failure (outpatients), and worsening of heart failure (hospitalized or treated in the emergency department), with all three relevant ejection fraction categories (heart failure with reduced ejection fraction, heart failure with mildly-reduced ejection fraction, and heart failure with preserved ejection fraction), is limited. Furthermore, only a few registries assess detailed aspects of guideline adherence, treatment decisions, and both in-hospital and long-term outcomes. Therefore, the Türkiye Heart Failure (TURK-HF) registry has been designed to address this gap in knowledge about the identification, management, and long-term prognosis of patients with heart failure in a real-world setting.

Start Date01 Dec 2024

Sponsor / Collaborator

Baskent University

CTRI/2024/11/076426 / Not yet recruitingNot Applicable

A Multicentre, Open Label, Randomized, Single-Dose, Two-Treatment, Parallel Arm Bioequivalence Study of Ferric Carboxymaltose Intravenous Injection (750 mg Iron/15 mL) of Dr. Reddy’s Laboratories Ltd, India, with that of Injectafer® [Ferric Carboxymaltose Injection (750 mg Iron/15 mL)] of American Regent Inc., USA Under Fasting Condition in Adult Patients with Iron Deficiency Anaemia, for whom Oral Iron Supplementation Alone was Not Adequate or is Not Appropriate - NIL

Start Date10 Nov 2024

Sponsor / Collaborator

Dr. Reddy's Laboratories Ltd.

CTRI/2024/10/075061 / Not yet recruitingPhase 3

COMPARISON OF EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE AND IRON SUCROSE FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN PREGNANCY - NIL

Start Date10 Nov 2024

Sponsor / Collaborator

National Health Laboratory

100 Clinical Results associated with Ferric Carboxymaltose

100 Translational Medicine associated with Ferric Carboxymaltose

100 Patents (Medical) associated with Ferric Carboxymaltose

940

Literatures (Medical) associated with Ferric Carboxymaltose

01 Feb 2025·JOURNAL OF CLINICAL ANESTHESIA

Ferric carboxymaltose with or without phosphate substitution in iron deficiency or iron deficiency anemia before elective surgery – The DeFICIT trial

Article

Author: Mair, Alexander ; Gasciauskaite, Greta ; Clavien, Pierre-Alain ; Schläpfer, Martin ; Opitz, Isabelle ; Karsai, Gergely ; Kaserer, Alexander ; Bischoff-Ferrari, Heike A ; Turina, Matthias ; Rössler, Julian ; Spahn, Donat R ; Akbas, Samira ; Hülsmeier, Andreas ; Spahn, Gabriela H ; Braun, Julia

BACKGROUND:

Iron deficiency anemia in the perioperative setting is treated predominantly with intravenous iron formulation, of which ferric carboxymaltose may induce hypophosphatemia by modulating fibroblast growth factor 23.

METHODS:

In this single-center, prospective, randomized, double-blind trial, we consented 92 adult patients scheduled for elective major abdominal or thoracic surgery. These patients either had isolated iron deficiency (plasma ferritin <100 ng/mL or transferrin saturation < 20 %) or iron deficiency anemia (hemoglobin (Hb) 100-130 g/L with plasma ferritin <100 ng/mL or transferrin saturation < 20 %). Preoperatively, participants received a single preoperative intravenous dose of ferric carboxymaltose and were then randomly assigned to receive either phosphate or placebo, administered orally three times a day for 30 days corresponding to an 18 mmol dose of daily phosphate supplementation in the intervention group. The primary endpoint was the minimum serum phosphate concentration during follow-up visits. The key secondary efficacy endpoint was mean perioperative hemoglobin concentration of postoperative days 0, 2 and 4, assessing the non-inferiority of additional phosphate supplementation.

RESULTS:

We randomly consented 46 patients in each group (mean ± SD age 56 ± 17 years, 57 % female). Minimal phosphate concentration was 0.49 ± 0.21 mmol/L in the treatment group and 0.42 ± 0.17 mmol/L in the placebo group (p = 0.12, two-sided p-value). Average mean hemoglobin was 110 ± 16 g/L in the treatment and 113 ± 13 g/L in the placebo group (p = 0.023, one-sided p-value for non-inferiority). Hypophosphatemia occurred in 32 patients (70 %) of the treatment group and in 39 patients (85 %) of the placebo group (odds ratio 0.15, 95 % CI from 0.02 to 0.77, p = 0.014). Secondary outcomes, such as rescue medication use, core muscle strength and MOCA test scores, did not differ between groups.

CONCLUSION:

Co-administration of oral phosphate supplementation to ferric carboxymaltose cannot prevent hypophosphatemia. However, hypophosphatemia occurs in fewer patients. Phosphate co-administration did not impede the treatment of iron deficiency anemia with ferric carboxymaltose.

31 Dec 2024·Journal of medical economics

Cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anemia in England

Article

Author: Iqbal, Tariq H. ; Kennedy, Nicholas ; Ahmed, Waqas ; Dhar, Anjan ; Pollock, Richard F.

AIMS:

Anemia is the most common extraintestinal complication of inflammatory bowel disease (IBD), with approximately half of cases caused by iron deficiency (ID). Intravenous iron is the preferred ID anemia (IDA) treatment where oral iron is contraindicated, ineffective or not tolerated, or where ID correction is urgent. The objective was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboxymaltose (FCM) in patients with IBD and IDA in England, in whom IV iron treatment is preferred.

MATERIALS AND METHODS:

A patient-level simulation model was developed, capturing quality of life (QoL) differences based on SF-36v2 data from the PHOSPHARE-IBD randomized controlled trial, monitoring and incidence of post-infusion hypophosphatemia, and number of iron infusions required. Analyses were conducted over a five-year time horizon from the Department of Health and Social Care (DHSC) perspective, with healthcare provider and societal perspectives adopted in separate analyses. Future costs and effects were discounted at 3.5% per annum and one-way and probabilistic sensitivity analyses were performed.

RESULTS:

FDI increased quality-adjusted life expectancy by 0.075 QALYs versus FCM from 2.57 QALYs to 2.65 QALYs per patient. Patients receiving FDI required 1.63 fewer iron infusions over the five-year time horizon, driving infusion-related cost savings of GBP 496 per patient (GBP 2,188 versus GBP 1,692) from the DHSC perspective. Costs of monitoring and treating hypophosphatemia after FCM were GBP 226, yielding total savings of GBP 722 per patient (GBP 2,414 versus GBP 1,692) over the five-year time horizon. FDI also led to reduced costs versus FCM in the societal and provider analyses and was therefore the dominant intervention across all three perspectives.

LIMITATIONS:

The analysis did not capture patient adherence, hypophosphatemic osteomalacia, or fractures.

CONCLUSIONS:

Results showed that FDI improved patient QoL and reduced direct healthcare expenditure versus FCM in patients with IBD and IDA in England.

31 Dec 2024·Future Science OA

Ferric carboxymaltose for iron deficiency in patients with heart failure: a systematic review and meta-analysis

Review

Author: Rehman, Faizan ur ; Fatima Zaidi, Syeda Mahrukh ; Zuhair, Varisha ; Rangwala, Burhanuddin Sohail ; Danish, Fnu ; Mussarat, Abdullah ; Shafique, Muhammad Ashir ; Mustafa, Muhammad Saqlain ; Khan, Aimen Waqar

Aim: Iron deficiency (ID) is associated with heart failure (HF) in a considerable proportion of patients. To improve the quality of life, lower the frequency of hospitalizations, and lower mortality rates of chronic HF patients (HF), this meta-analysis will look into the role of iron supplementation using ferric carboxymaltose (FCM). Methods & results: From inception until 1 October 2023, we conducted a thorough literature search of electronic databases for peer-reviewed publications. Around 5229 HF patients were included, of which 2691 received FCM while 2538 received placebo. Conclusion: FCM reduces HF-related hospitalizations but doesn't improve overall or cardiovascular mortality in those with HF and ID. The overall results support FCM's role in managing iron deficiency in heart failure.

News (Medical) associated with Ferric Carboxymaltose

19 Mar 2024

·www.prnewswire.com

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

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 . 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 nails14, 16, craving non-food items such as dirt, clay and ice17, and an inability to concentrate13, 18. In children, iron deficiency anemia can significantly impair cognitive and motor development19,20,21. 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: . References 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. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994. Ferinject Product Monograph. CSL Vifor, St. Gallen, Switzerland. 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. 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 . Del Pinto et al. Eur Heart J Suppl. 2022 Nov; 24(Suppl I): I96–I99). Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013;5(9):3730-9. doi:10.3390/nu5093730. 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. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268–275. Classes of Heart Failure. American Heart Association. May 2017. Data on file. PSUR report. CSL Vifor, St. Gallen, Switzerland. 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. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: E0C7?sequence=1. Last accessed: November 2023. 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. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38. 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. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5. 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. 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. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: . Last accessed: November 2023. 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. 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 [email protected] SOURCE Vifor International AG (CSL Vifor)

Drug ApprovalAHA

29 Jan 2024

·www.prnewswire.com

Renal Anemia Therapeutics Market to Record Growth of USD 2.08 billion from 2023 to 2028, Akebia Therapeutics Inc and Amgen Inc to emerge as Some of the Key Companies - Technavio

NEW YORK, Jan. 29, 2024 /PRNewswire/ -- The renal anemia therapeutics market is estimated to grow by USD 2.08 billion during 2023-2028, growing at a CAGR of 7.59%. Akebia Therapeutics Inc and Amgen Inc to emerge as some of the major companies. Akebia Therapeutics Inc offers adadustat. The report includes information on the product launches, sustainability, and prospects of leading companies including Akebia Therapeutics Inc., Amgen Inc., AstraZeneca Plc, Bayer AG, Covis Pharma GmbH, CSL Ltd., Daiichi Sankyo Co. Ltd., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., FibroGen Inc., GlaxoSmithKline Plc, Japan Tobacco Inc., JCR Pharmaceticals Co. Ltd., Kirin Holdings Co. Ltd., Mitsubishi Chemical Group Corp., Pfizer Inc., Pharmacosmos AS, Sun Pharmaceutical Industries Ltd., Travere Therapeutics Inc., and Astellas Pharma Inc.. For Comprehensive details on the market size of historic period(2018 to 2022) and forecast period (2024-2028) - View the Free Sample report Continue Reading Technavio has announced its latest market research report titled Global Renal Anemia Therapeutics Market 2024-2028 The market is fragmented; the companies are competing with competitors and are trying to get greater market share. The market is growing, and chances of new entrants cannot be overlooked. The major companies have well-established economies of scale and presence and generally rely on positioning, technological advances, and the price of the products - The report provides a full list of key companies, their strategies, and the latest developments. Buy Now The growing geriatric population drives the growth. The prevalence of chronic diseases like CKD, is high among the aging population. There is a direct relationship between aging and susceptibility to infections, as it deteriorates the immune system. Apart from the impaired functioning of the immune system, the reduced functioning of organs also increases the chances of acquiring diseases such as CKD. The growing adoption of biosimilars is an emerging trend shaping growth. Side effects of oral administration of renal anemia drugs is a major challenge hindering growth. Technavio has identified key trends, drivers, and challenges, which will help clients improve their strategies to stay ahead of their competitors. - View the Free Sample Report The report includes competitive analysis, a proprietary tool to analyze and evaluate the position of companies based on their industry position score andperformance score. The competitive scenario categorizes companies based on various performance indicators. Some of the factors considered include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, and growth in market share, among others. Segmentation by Type The growth by the IV segment will be significant during the forecast period. The predominant segment is medications administered through the IV route, primarily attributed to the growing adoption and the convenience of absorption. Additionally, ferric carboxymaltose, sucrose, dextran, and other agents like ferumoxytol and isomaltoside contribute to this category. Gain instant access to 17,000+ research reports. Technavio's SUBSCRIPTION platform Applications The Renal Anemia Therapeutics Market is a dynamic landscape where medical interventions target conditions such as Chronic Kidney Disease (CKD) through a range of treatments. Erythropoiesis-Stimulating Agents (ESAs), including Darbepoetin Alfa and Epoetin Alfa, play a pivotal role in managing anemia associated with renal diseases. Innovative therapies like Roxadustat, a Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) Inhibitor, showcase advancements in addressing anemia linked to CKD. Iron Supplements, both intravenous and oral, are essential components, alongside Ferric Citrate and Ferric Gluconate, contributing to comprehensive anemia management. The market encompasses diverse modalities, from Hemodialysis to Peritoneal Dialysis, recognizing the significance of tailored approaches. Related Reports The hormone replacement therapy (HRT) market size is estimated to grow by USD 8.44 billion, at a CAGR of 6.67% between 2023 and 2028. The equine supplement products market size is estimated to grow by USD 20,352.14 at a CAGR of 4.19% between 2023 and 2028. 1 Executive Summary 2 Landscape 3 Sizing 4 Historic Size 5 Five Forces Analysis 6 Segmentation by Type 7 Segmentation by Distribution Channel 8 Customer Landscape 9 Geographic Landscape 10 Drivers, Challenges, and Trends 11 Company Landscape 12 Company Analysis 13 Appendix About US Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging trends and provide actionable insights to help businesses identify opportunities and develop effective strategies to optimize their positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable insights to identify opportunities in existing and potential markets and assess their competitive positions within changing scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

24 Nov 2023

·www.prnewswire.com

Iron Deficiency Day 2023: CSL Vifor calls for access to iron deficiency diagnosis and treatment

Iron Deficiency Day unites a strong global coalition raising awareness on the serious health impact of iron deficiency and iron deficiency anemia1This year, the spotlight is on the importance of early iron deficiency diagnosis and treatment and its impact on quality of life ST. GALLEN, SWITZERLAND, Nov. 24, 2023 /PRNewswire/ -- This Sunday, 26 November, marks Iron Deficiency Day, a day dedicated to raising awareness about the importance of diagnosing and treating iron deficiency and iron deficiency anemia. Supported by an alliance of international patient organizations and health advocacy groups, CSL Vifor takes a leading role annually to educate people about the importance of iron for the body and what can happen if iron levels are not properly managed. It encourages people to become better informed and to seek medical advice from their physicians. Continue Reading Take Iron Seriously logo Takeironseriously.com campaign visual: Listen to your body and take iron seriously "Iron Deficiency Day stands as a mainstay of our ongoing commitment to underscore the significance of taking iron seriously", said Hervé Gisserot, General Manager CSL Vifor. "Despite the serious consequences and high prevalence of iron deficiency, the condition remains under-recognized. At CSL, we are driven by our promise to patients around the world and together with our partners, we are committed to further building awareness, helping patients recognize their symptoms, and improving access to care." Although iron deficiency affects one in three people worldwide2, it is most prevalent in premenopausal women, pregnant women, and children under five3. However, early access to diagnosis and treatment remains a challenge. Disparities in gender4, educational status4,5 and geography5 are just some of the many aspects that may further limit access to information, diagnosis, and medical support. To address this unmet need, CSL Vifor raises awareness of iron deficiency and iron deficiency anemia across Europe, South America, the Middle East, Asia and Australia. "Iron deficiency affects about half of the patients suffering from chronic kidney disease. However, geographic and socio-demographic barriers often prevent many patients from receiving a timely diagnosis", commented Daniel Gallego, President of the European Kidney Patient's Federation. "As iron deficiency and iron deficiency anemia is easily diagnosed and treatable, it is crucial that every individual has access to resources for understanding the condition, to benefit from early diagnosis and treatment regardless of their background or circumstances. As ultimately this could lead to improved quality of care and life of those living with CKD." Iron Deficiency Day is endorsed by multiple international organizations including the Heart Failure Policy Network, European Kidney Health Alliance, Global Heart Hub and Croí the West of Ireland Cardiac Foundation. CSL Vifor encourages the global community to join and raise awareness on iron deficiency by promoting education and early intervention. To learn more about the importance of equity, early diagnosis and recognizing symptoms of iron deficiency, visit . Use hashtags #TakeIronSeriously and #IDDay2023 on X (Twitter) and LinkedIn. 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, . Notes to Editors Takeironseriously.com is intended to provide educational information to an international audience outside the US; it is available in 17 languages. All information on the site is intended for educational purposes only and should not be used to replace a discussion with a healthcare professional. All decisions regarding patient care must be handled by a healthcare professional and be made based on the unique needs of each patient. About iron deficiency 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 worldwide6, yet despite the serious consequences and high prevalence7, it remains an under-recognized condition. The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being8. Even without anemia, iron deficiency can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality8. Common symptoms include fatigue8,9,10 pale skin9, brittle nails9, 11, craving non-food items such as dirt, clay and ice12, and an inability to concentrate8, 13. In children, iron deficiency can significantly impair cognitive and motor development14. Left untreated, iron deficiency can develop into iron deficiency anemia. 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: . . References Hassan, Tamer Hasan et al. "Impact of Iron Deficiency Anemia on the Function of the Immune System in Children." Ed. Esaki M. Shankar. Medicine 95.47 (2016): e5395. PMC. Web. 12 June 2018. Vos, T., et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. The Lancet, 388(10053), 1545–1602. Hercberg S, et al. Iron deficiency in Europe. Public Health Nutr. 2007;4(2b). Alfadhul S, Kadhum S. The significance of awareness about iron deficiency anaemia in its prevention among Iraqi pregnant women attending primary healthcare centres. Family Medicine & Primary Care Review. 2023;25(3):250-255. doi:10.5114/fmpcr.2023.130084. Safiri, S., Kolahi, AA., Noori, M. et al. Burden of anemia and its underlying causes in 204 countries and territories, 1990–2019: results from the Global Burden of Disease Study 2019. J Hematol Oncol 14, 185 (2021). . 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. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: E0C7?sequence=1. Last accessed: November 2023. 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. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38. 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. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5. 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. 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. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: . Last accessed: November 2023. SOURCE Vifor International AG (CSL Vifor)

100 Deals associated with Ferric Carboxymaltose

External Link

KEGG	Wiki	ATC	Drug Bank
D08920	Ferric Carboxymaltose	B03A	DB08917

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Iron deficiency	US	American Regent, Inc.	31 May 2023
Anemia, Iron-Deficiency	EU	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	IS	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	LI	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	NO	Vifor SA	26 Jun 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure, Systolic	Phase 3	BR	Vifor Pharma AG	24 May 2024
Neoplasms	Phase 3	US	American Regent, Inc.	23 May 2015
Restless Legs Syndrome	Phase 3	US	American Regent, Inc.	01 Jan 2015
Diabetes Mellitus, Type 2	Phase 3	DE	Vifor Pharma AG	01 Aug 2012
Lymphoma	Phase 3	DE	Vifor Pharma AG	01 May 2010
Lymphoma	Phase 3	SE	Vifor Pharma AG	01 May 2010
Inflammatory Bowel Diseases	Phase 3	RU	Vifor Pharma AG	01 Feb 2009
Colitis, Ulcerative	Phase 3	AT	Vifor Pharma AG	01 Oct 2008
Crohn Disease	Phase 3	AT	Vifor Pharma AG	01 Oct 2008
Menorrhagia	Phase 3	US	American Regent, Inc.	01 Oct 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03037931 (HEART-FID, CTgov)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	grgfzzawex(gwjnnszluh) = dvtqpfugwg izsydtqhov (gpwlafkjbr, sctcnkeaaq - iokzjrtxnz) View more	-	03 Jul 2024
				Placebo (Placebo)	grgfzzawex(gwjnnszluh) = ayifzaoxit izsydtqhov (gpwlafkjbr, wbqairoqki - hizvuraixx) View more
EHA2024	Not Applicable	Anemia, Iron-Deficiency	-	Ferric Carboxymaltose	xsniwbidpw(nybmtigtji): RR = 2.75 (95% CI, 2.29 - 3.3), P-Value = <0.0001 View more	Negative	14 May 2024
				Iron Sucrose
NCT01690585 (Pubmed \| Age Ageing) Manual	Phase 3	Gastrointestinal Hemorrhage	59	Ferric carboxymaltose	dyaxmqzeqs(pwjqqzlfnz) = strhjxidel pnbfwzdhdf (mskycygzza ) View more	Positive	01 May 2024
				Placebo	dyaxmqzeqs(pwjqqzlfnz) = wjowlpdasb pnbfwzdhdf (mskycygzza ) View more
ASH2023	Not Applicable	-	289	Ferric Carboxymaltose (FCM)	petacipxif(bdqayqckem) = fztrtjdyfg tymhjygxeq (chtrdydydq )	-	11 Dec 2023
				Ferric Derisomaltose (FDI)	petacipxif(bdqayqckem) = fsgzemznnt tymhjygxeq (chtrdydydq )
SOHO2023	Not Applicable	-	-	Ferric Carboxymaltose (FCM)	nfmditmada(mthbenogaa): risk ratio = 0.97 (95% CI, 0.62 - 1.51), P-Value = 0.86 View more	-	01 Sep 2023
				Iron Sucrose (IS)
ESC2023	Not Applicable	-	101	Ferric carboxymaltose	gamtjtnyml(fucbejdmeh) = ovzgmrwhpp kuxbzaxhmy (nbdizzewaw )	-	28 Aug 2023
NCT03037931 (HEART-FID, Pubmed \| N Engl J Med)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric carboxymaltose	sxemrtucrv(nzppikehhc) = lhuhdrszzd xrtpvudzer (ajuhqbhldl )	-	26 Aug 2023
				Placebo	sxemrtucrv(nzppikehhc) = emrwenafsg xrtpvudzer (ajuhqbhldl )
NCT03037931 (HEART-FID, Pubmed \| Am Heart J)	Not Applicable	Iron deficiency \| Heart Failure	3,065	Ferric Carboxymaltose	slzoumashh(zjudskamgx) = nfthawuqgb dgbybxyogz (pyykzfvojm, 196 - 350) View more	-	18 Aug 2023
NCT03218384 (CTgov)	Phase 2	Iron deficiency \| Heart Failure	20	31P MRS/MRI+Ferric Carboxymaltose (Ferric Carboxymaltose)	xdhmpzefje(wiurjwytwm) = cjtemalqzc vhwcysrtmc (xmyurbgygu, mcqdyxtpak - dogekpafkv) View more	-	05 Jul 2023
				31P MRS/MRI (Placebo)	xdhmpzefje(wiurjwytwm) = qnedtzkhbz vhwcysrtmc (xmyurbgygu, ieongekjgp - fhezxxewpy) View more
ESC2023	Not Applicable	Heart failure with normal ejection fraction iron deficiency	235	Ferric carboxymaltose	rvrirodxpk(xrwqadpkip) = nutfulwyyu uohswqijut (pxahsjzpkq ) View more	-	20 May 2023

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