- Idefirix® becomes the first and only product recommended by SMC for the desensitization of highly sensitized patients waiting for a kidney transplant1
- SMC considers Idefirix® to be a clinically effective and cost-effective treatment within current clinical practice 1
-
This is an important milestone for highly sensitized Scottish patients awaiting a kidney transplant, as
NHS Scotland funding for Idefirix® will now be made available to hospitals inScotland -
The SMC decision follows the recent positive NICE recommendation for Idefirix® in
England ,Wales and Northern Ireland,2 expanding access for eligible patients across theUK
The recommendation marks an important milestone for patients in
The approval of Idefirix® offers a new option to these highly sensitized patients in need of transplant to increase the chances of successful matching with a deceased donor organ.
Dr
"We are thrilled that the SMC has recommended Idefirix® as the first licensed therapy for highly sensitized kidney patients in
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For more information:
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
Notes to editors
About Idefirix® (imlifidase)
Idefirix® is an enzyme derived from the bacterium Streptococcus pyogenes and has the ability to specifically target and cleave all classes of immunoglobulin G (IgG) antibodies.11
Idefirix® is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).12 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.5 Once they are inactivated with Idefirix®, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, 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.10,13-14
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%.15 ESRD poses a significant global health burden, affecting nearly 2.5 million patients worldwide.14 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
Scottish Medicines Agency . Available at: https://www.scottishmedicines.org.uk/medicines-advice/imlifidase-idefirix-full-smc2445/ accessedSeptember 2022 .-
NICE. Available at: https://www.nice.org.uk/guidance/ta809. Last accessed
September 2022 . European Medicines Agency . Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessedSeptember 2022 .- Mumford L, et al. Transpl Immunol. 2021; 64:101354.
-
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.
Database Global Observatory on Donation and Transplantation. Available at: http://www.transplant-observatory.org/data-charts-and-tables/.- 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. Available from: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf. Last accessedSeptember 2022 .- Winstedt L, et al. PLoS One 2015; 10(7): e0132011.
- Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
- Jordan SC, et al. Transplantation October 21, 2020 - volume online first issue.
NIH . What is kidney failure?, 2018. Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure Last accessedSeptember 2022 .- Newsletter Transplant 2020. pp 58-60
https://news.cision.com/hansa-biopharma-ab/r/the-scottish-medicines-consortium--smc--recommends-use-of-hansa-biopharma-s-idefirix---imlifidase--a,c3629349
https://mb.cision.com/Main/1219/3629349/1625587.pdf
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