Israel is the first market outside ofEurope to grant regulatory approval for Idefirix®- The decision by
Israel's regulatory authority provides highly sensitized patients inIsrael with the opportunity to receive Idefirix® as desensitization treatment -
The approval to use Idefirix® as defined in indication approved by the
European Medicines Agency (EMA)1,2
Idefirix® is the first and only medicine licensed for desensitization of highly sensitized patients prior to kidney transplantation, allowing these patients to access a life-changing kidney transplantation from a deceased donor.
"The regulatory approval of Idefirix® in
Highly sensitized kidney patients 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. 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, hospitalizations and additional costs.3-5
"The approval of Idefirix® in
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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
Medison contact:
M: +972 3 925 0349
E: mayan@medisonpharma.com
Notes to editors
About 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.6
IgG antibodies targeted specifically at the transplanted kidney are known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs).7 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.8 Once they are inactivated with imlifidase, 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 imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four Phase 2 open-label, single-arm, six-month clinical trials.5, 7,9,10
Imlifidase 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%.11 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.9 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
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. To learn more visit www.medisonpharma.com and follow us on LinkedIn.
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 - 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
-
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 -
Jordan SC, et al. Transplantation
October 21, 2020 - volume online first issue - Winstedt L, et al. PLoS One 2015; 10(7): e0132011
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.
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-and-medison-pharma-announce-marketing-authorization-in-israel-for-idefirix---imlifid,c3534066
https://mb.cision.com/Main/1219/3534066/1555072.pdf
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