Göteborg, Sweden, April 2024 /WiredBusiness/ – Hansa Biopharma, a leading biopharmaceutical company focused on immunomodulation therapies, has released positive efficacy and safety results from its European post-authorization study evaluating Idefirix® (imlifidase) in kidney transplantation. Demonstrating a 90% one-year graft failure-free survival rate, these findings offer significant clinical value to the transplantation community and reinforce the ongoing regulatory pathway for full marketing authorization of Idefirix® across Europe.

Idefirix® is a first-in-class enzyme that rapidly cleaves human IgG antibodies, allowing kidney transplant candidates highly sensitized to donor-specific antigens—patients traditionally at high risk for antibody-mediated rejection—the opportunity to receive life-saving organs. Currently authorized under conditional marketing authorization in the European Union, Idefirix® aims to improve transplant outcomes and reduce the incidence of antibody-related graft complications among sensitized patients.

The European post-authorization study enrolled a diverse cohort of kidney transplant recipients who were highly sensitized and subsequently treated with Idefirix® prior to transplantation. The primary endpoint evaluated was one-year graft failure-free survival, a critical measure of transplant success and patient quality of life. Achieving an impressive 90% survival rate, the data significantly align with the anticipated benefits evidenced in previous clinical trials, further validating Idefirix®'s robust efficacy profile.

In parallel, the safety profile observed during the study was consistent with prior clinical trial experience and deemed favorable. Idefirix® was generally well tolerated with manageable adverse events, underscoring its suitability for use in complex transplant cases where current treatment options remain limited. This reinforces confidence among healthcare providers regarding the risk-benefit balance of incorporating Idefirix® into the immunosuppressive therapeutic regimen for sensitized kidney transplant patients.

Based on these compelling study outcomes, Hansa Biopharma has initiated submission processes with the European Medicines Agency (EMA) to convert Idefirix®'s conditional marketing authorization into a full marketing authorization. Attaining full authorization would enhance accessibility and support broader clinical adoption of this innovative treatment, ultimately improving transplant survival rates across Europe.

Henrik Wigzell, CEO of Hansa Biopharma, commented, "The results from this post-authorization study underscore the important role Idefirix® plays in enabling kidney transplantation for patients previously considered ineligible due to high immunological risk. We remain committed to advancing access to this transformative therapy and supporting physicians in delivering optimal care for sensitized transplant patients."

This announcement marks a significant milestone in Hansa Biopharma’s mission to develop and commercialize innovative treatments that address unmet needs in organ transplantation. With further regulatory progress anticipated, Idefirix® is positioned to become a cornerstone therapy in the management of antibody-mediated risks in kidney transplantation.

For additional information on Idefirix® and Hansa Biopharma’s ongoing clinical and commercialization efforts, please visit the company’s website.