(Información remitida por la empresa firmante)
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient’s kidney function is less than 15%.16 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.16 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. In Australia there were approximately 28,000 kidney patients needing renal replacement therapy in 2021.17,18About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program based on the Company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com.
Full Australian product information can be accessed from the TGA via this link here.
©2023 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.
References
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2. Winstedt L, et al. PLoS One 2015; 10(7): e0132011
3. Lorant T, et al. Am J Transplant 2018;18(11):2752-2762.
4. Jordan SC, et al. Transplantation October 21 2020 – volume online first issue.
5. Sypek MP, et al. (2021) Transplantation 105(6): 1317-1325
6. The Australia and New Zealand Dialysis and Transplant Registry (ANZDATA). Last accessed: June 2023.
7. ANZDATA 45th Annual Report 2022 (Data to 2021). Last accessed: June 2023
8. Trial NCT03611621. Available at https://classic.clinicaltrials.gov/ct2/show/NCT03611621
9. Trial NCT05369975. Available at https://classic.clinicaltrials.gov/ct2/show/NCT05369975
10. Trial NCT04935177. Available at https://classic.clinicaltrials.gov/ct2/show/NCT04935177
11. Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reporting
12. Redfield R, et al. Nephrol Dial Transplant 2016; 31:1746–1753
13. Lonze BE, et al. Ann Surg 2018; 268(3):488–496
14. European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf. Last accessed: June 2023
15. Manook M, et al. Lancet 2017; 389(10070):727-734.
16. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
17. ANZDATA Registry. 45th Report, Chapter 2: Prevalence of Kidney Failure with Replacement Therapy. Australia and New Zealand Dialysis and Transplant Registry, Adelaide, Australia. 2022. Available at: http://www.anzdata.org.au Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR).
18. OPTN/SRTR 2021 Annual Data Report Table KI 2. Published 2023. Accessed 10 July 2023
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