-
Recommendation to use Idefirix® (imlifidase) as defined in indication approved by the
European Medicines Agency (EMA)1,2 -
Decision provides highly-sensitized patients in
Sweden with the opportunity to receive Idefirix® as desensitization treatment -
Commercial launch activities for Idefirix® in
Europe progressing as planned
"Idefirix® is the first desensitization treatment to demonstrate positive outcomes in clinical settings. It reduces the risk of hyperacute rejection following transplantation by inactivating the immunoglobulin G in highly sensitized patients," said Associate Professor
Kidney transplant patients are classed as highly sensitized if they have antibodies against many human leukocyte antigens (HLA), which can cause tissue damage and potentially transplant rejection.4 Risk factors for developing HLA antibodies that cause sensitization include previous transplantation, blood transfusion and pregnancy.5 These patients are unlikely to be offered a kidney transplant and spend a longer time on the waiting list with an increased risk of dying while waiting for a suitable donor.6,7
"Kidney patients with high levels of HLA antibodies have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis," said Håkan Hedman, Chairman of the
Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization.7-9
"At Hansa, our mission is to significantly improve the lives of rare disease patients with serious unmet medical needs, bringing highly innovative medicines from the laboratory to the patients", said Søren Tulstrup, President and CEO,
--- ENDS ---
For more information:
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
M: +46 (0) 768 198 326
E: katja.margell@hansabiopharma.com
Notes to editors
About Idefirix® (imlifidase)
Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes and has the ability to specifically target and cleave (or break) all classes of immunoglobulin G (IgG) antibodies.10
IgG antibodies targeted specifically at the transplanted kidney are known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs).11 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.4 Once they are inactivated with Idefirix®, there is a window of opportunity for the transplant to take place. By the time the body starts renewing the depleted antibodies, the patient will be receiving immunosuppressive therapy to reduce the risk of organ rejection.
The efficacy and safety of Idefirix® as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.9,11-13
Idefirix® was granted conditional European Marketing Authorization from the EMA in
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.14 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.13 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits compared to long-term dialysis. There are approximately 80,000 kidney patients on transplant waiting lists across the
Full product information can be accessed via the initial Summary of Product Characteristics found here.
About
References
- https://janusinfo.se/download/18.13de125317a50669b3accae/1624877753964/Idefirix-(imlifidas)-210628.pdf
European Medicines Agency . Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessedMay 2021 Swedish Dental and Pharmaceutical Benefits Agency . Available at: https://www.tlv.se/download/18.1d0e11ca17750df902370541/1614947000269/bed210127_idefirix.pdf. Last accessedMay 2021 -
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. Last accessedApril 2021 -
Manook M, et al.
Lancet 2017; 389(10070):727-734 - Redfield R, et al. Nephrol Dial Transplant 2016; 31:1746-1753
- Lonze BE, et al. Ann Surg 2018; 268(3):488-496
- Kuppachi S, et al. Transpl Int 2020; 33(3):251-259
- Lorant T, et al. Am J Transplant 2018;18(11):2752-2762
Hansa . Idefirix® Summary of Product Characteristics- Jordan SC, et al. N Engl J Med 2017; 377(5):442-453
- Winstedt L, et al. PLoS One 2015; 10(7): e0132011
-
Jordan SC, et al. Transplantation
October 21, 2020 - volume online first issue NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure. Last accessedMay 2021 - Newsletter Transplant 2020. pp 58-60.
[*] Pharmacy purchasing pricing, currently published in
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-decision-by-swedish-new-therapies-council-to-recommend-use-of-idefirix---i,c3375727
https://mb.cision.com/Main/1219/3375727/1437770.pdf
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