Hansa Biopharma announces positive early access decision from the French Haute Autorité de Santé to use Idefirix (imlifidase) as a desensitization treatment for highly sensitized kidney transplant patients

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  • 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

Lund, Sweden, February 25, 2022. Hansa Biopharma AB“Hansa” (Nasdaq Stockholm: HNSA), the pioneer of enzyme technology for rare immunological diseases, today announces that its first-in-class treatment Idefirix® (imlifidase) has been granted post-marketing early access (Access authorizationes early) in France by French A (High Authority of Health) for use in the desensitization of highly sensitized adult patients prior to kidney transplantation, in accordance with the patient population specified in the Marketing Authorization received from European Medicines Agency (EMA).1,2

The goal of early access programs in France is to accelerate access to innovative medicines before (AP1) or after (AP2) MA (and before completion of the full P&R process), as in the case of Idefirix® when all of the following conditions provided for in article L.5121-12 of the French public health code (CSP) are met:

· 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 France. Permission was granted on the basis of Hansa case filed in December 2021who gave a positive opinion of the Transparency Committee. Full details of the early access program are available on the HAS website.

Approximately 3,600 kidney transplants are performed each year in FranceAccording to the Biomedicine Agency, in 2020, hyperimmune patients represented 11.1% of kidney transplant recipients, while the proportion of hyperimmune patients on the active kidney transplant waiting list was 23.7%.

“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. , Hansa Biopharma. “Delivering Idefirix® as a new therapeutic option for highly sensitized renal patients in France demonstrates our commitment to improving the lives of patients with rare immunological diseases.”

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 Europe continue to progress. The underwriting and reimbursement processes were completed in Sweden and the Netherlandsas well as on an individual hospital basis in Finland and Greece. Market access procedures are underway in 14 countries, including Germany, France, Italy and the UK (UK). A Health Technology Assessment (HTA) file for Spain was submitted in January 2022which completed HTA deposits in the five largest markets of Europe.

This is information that Hansa Biopharma AB is required to make public in accordance with the EU Market Abuse Regulation. The information has been submitted for publication, through the contact person listed below, to 11:50 p.m. CET to February 25, 2022.

— ENDS —

For more information:

Klaus Sindahl, Head of Investor Relations
M: +46 (0) 709 298 269
E: [email protected]

Katja Margell, Corporate Communications Manager

M: +46 (0) 768 198 326

E: [email protected]

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

Hansa is currently collecting additional clinical evidence and will submit additional efficacy and safety data based on an observational follow-up study and a post-approval efficacy study. Imlifidase has been examined as part of the of the European Medicines Agency (EMA) PRIority MEdicines (PRIME), which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.2

Imlifidase obtained conditional European Marketing Authorization from the EMA in August 2020 for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive cross-test against an available deceased donor. Use of imlifidase should be reserved for patients who are unlikely to be transplant recipients under the available kidney allocation system, including prioritization programs for highly sensitized patients.2 Conditional approval allows the Agency to recommend a medicine for marketing authorization in cases where the benefit of the immediate availability of medicines for patients outweighs the risk that all the data may not yet be available.

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 European Union.14

Full product information can be accessed via the initial Summary of Product Characteristics found here.

On Hansa Biopharma

Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company with a mission to develop and commercialize innovative, life-saving and life-changing treatments for patients with rare immunological diseases. Hansa has developed a first-in-class immunoglobulin G (IgG) cleaving enzyme therapy that has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program based on the Company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in the fields of transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based at Lund, Swedenand operates in Europe and the we The company is listed on Nasdaq Stockholm under the symbol HNSA. Learn more about https://hansabiopharma.com.

The references

  1. 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
  2. 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
  3. European Medicines Agency. Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last access May 2021
  4. Global Observatory on donation and transplantation, http://www.transplant-observatory.org/
  5. Lonze BE, et al. Anne Surg 2018; 268(3):488-496
  6. Kuppachi S, et al. Transpl Int 2020; 33(3):251-259
  7. Lorant T, et al. Am J Registry 2018;18(11):2752-2762
  8. Hansa. Idefirix® Summary of Product Characteristics
  9. Jordan SC, et al. N English J med 2017; 377(5):442-453
  10. 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 access April 2021
  11. Lorant T, et al. Am J Registry 2018;18(11):2752-2762
  12. Jordan SC, et al. Transplantation October 21, 2020 – online volume first issue
  13. Winstedt L, et al. PLoS One 2015 ; 10(7): e0132011
  14. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure. Last access May 2021
  15. Newsletter Transplantation 2020. pp 58-60.

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