- Decision to use Idefirix® (imlifidase) commercially available in the indication approved by the
European Medicines Agency (EMA)1,2
- Decision provides highly sensitized patients
France with the possibility of receiving Idefirix® immediately as a desensitization treatment - Idefirix® commercial launch activities in
Europe continue to progress
The goal of early access programs in
· There is no suitable treatment available on the market;
· The initiation of treatment cannot be postponed;
· The efficacy and safety of the medicine are strongly presumed based on the results of clinical trials; and
· The medicinal product is presumed to be innovative, in particular compared to a clinically relevant comparator.
Approval of this early access program for Idefirix® is valid for one year from the date of the decision, funded by the national security system, and is effective in all kidney transplant centers in
Approximately 3,600 kidney transplants are performed each year in
“Patients with kidneys with high levels of HLA antibodies 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 dialysis. long-term,” says Søren Tulstrup, President and CEO. ,
Long-term dialysis can place a significant burden on patients and healthcare systems and is associated with reduced health-related quality of life and increased risk of mortality and hospitalization.4-6
Commercial launch and market access efforts for Idefirix® in
This is information that
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For more information:
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Notes to Editors
About imlifidase
Imlifidase is an enzyme derived from bacteria Streptococcus pyogenes and has the ability to specifically target and cleave (or disrupt) all classes of immunoglobulin G (IgG) antibodies.7
IgG antibodies that specifically target the transplanted kidney are known as preformed human leukocyte antigens (HLA) or donor-specific antibodies (DSA).8 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the graft. 9 Once they are inactivated with imlifidase, there is a window of opportunity for transplantation to take place. As the body begins to renew depleted antibodies, the patient will receive immunosuppressive therapy to reduce the risk of organ rejection.
The efficacy and safety of imlifidase as a pre-transplant therapy to reduce donor-specific IgG has been studied in four open-label, single-arm, six-month Phase 2 clinical trials. 6, 8,11,12
Imlifidase obtained conditional European Marketing Authorization from the EMA in
About kidney failure
Renal failure can progress to kidney failure or end-stage renal disease (ESRD), identified when a patient’s kidney function is less than 15%.13 ESRD poses a significant health burden, affecting nearly 2 .5 million patients worldwide.11 A kidney transplant is the treatment of choice for appropriate patients with ESRD, as it offers improved survival and quality of life 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.
On
The references
- https://www.has-sante.fr/jcms/p_3319018/fr/decision-n-2022-0086/dc/sem-du-23-fevrier-2022-de-la-presidente-de-la-haute- health-authority-taken-in-the-name-of-the-college-carrying-authorization-for-early-access-to-the-idefirix-specialty
European Medicines Agency . Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessMay 2021 Global Observatory on donation and transplantation, http://www.transplant-observatory.org/- Lonze BE, et al. Anne Surg 2018; 268(3):488-496
- Kuppachi S, et al. Transpl Int 2020; 33(3):251-259
- Lorant T, et al. Am J Registry 2018;18(11):2752-2762
Hansa . Idefirix® Summary of Product Characteristics- Jordan SC, et al. N English J med 2017; 377(5):442-453
- Eurostam report (A
Europe -Europe-wide strategy to improve transplantation of highly sensitized patients based on acceptable HLA incompatibilities.) Available at https://cordis.europa.eu/project/id/305385/reporting . Last accessApril 2021 - Lorant T, et al. Am J Registry 2018;18(11):2752-2762
- Jordan SC, et al. Transplantation
October 21, 2020 – online volume 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 accessMay 2021 - Newsletter Transplantation 2020. pp 58-60.
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-positive-early-access-decision-by-french-haute-autorite-de-sante-to-use-id, c3515009
https://mb.cision.com/Main/1219/3515009/1541404.pdf
(c) Decision 2022. All rights reserved., sources