-
Idefirix® is among a few selected medicines to be granted ASMR 3 (Amélioration du service médical rendu) by the
French Transparency Commission , which represents a level of clinical added benefit, and has also received SMR Important1 -
The opinion by the
Transparency Commission follows after Idefirix® was granted a funded Early Access Program by the French Haute Autorité de Santé (HAS) in February this year
-
Commercial launch activities for Idefirix® in
Europe continue to progress
ASMR is a grading system based on seriousness of a disease, evidence of efficacy, added benefit versus comparators, safety, treatment landscape and relevance for public health. The ASMR 3 status granted to Idefirix® could enable faster price and reimbursement. Idefirix® has also received SMR Important (Service Médical Rendu), which is reflecting the product's actual medical benefit. Important is the highest level of reimbursement possible. Of all ASMR ratings granted in 2020, only 5,8% received ASMR level 3.2
"Receiving ASMR 3 is a rare event and a testament to both the level of innovation represented by Idefirix® and the high degree of unmet need among highly sensitized patients in
The TC opinion has been adopted by the
Approximately 3,600 kidney transplantations are carried out annually in
Commercial launch and market access efforts for 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
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.4
IgG antibodies targeted specifically at the transplanted kidney are known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs).5 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.6 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.7,5,8,9
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.8 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://www.has-sante.fr/jcms/fc_2875171/fr/resultat-de-recherche?text=Idefirix&tmpParam=&opSearch=
- Comité Economique des Produits de Santé and Commission de la Transparence
- 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-autorite-de-sante-prise-au-nom-du-college-portant-autorisation-d-acces-precoce-de-la-specialite-idefirix
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 - Lorant T, et al. Am J Transplant 2018;18(11):2752-2762
-
Jordan SC, et al. Transplantation
October 21, 2020 - volume online first issue - Winstedt L, et al. PLoS One 2015; 10(7): e0132011
European Medicines Agency . Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessedMay 2021 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-granted-added-benefit-asmr-3-by-french-transparency-commission-for-idefirix---imlifi,c3549607
https://mb.cision.com/Main/1219/3549607/1566515.pdf
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