Hansa Biopharma’s PAES confirms Idefirix delivers durable one-year graft survival in highly sensitized kidney transplant patients, supporting full EU approval plans by 2026.
Written By: Disha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Hansa Biopharma reported positive topline results from the European 20-HMedIdeS-19 Post Authorization Efficacy Study (PAES), confirming the long-term clinical benefit of Idefirix in highly sensitized patients undergoing HLA-incompatible kidney transplantation.
The open-label confirmatory study met its primary endpoint, with 90% of patients remaining free from graft failure at one year following imlifidase-enabled transplantation. These findings fulfill a key post-authorization requirement tied to the conditional European approval of Idefirix.
Durable Transplant Outcomes
Secondary endpoints reinforced the durability of transplant outcomes. At one year, mean estimated glomerular filtration rate (eGFR) reached 52.4 mL/min/1.73 m², graft survival was 92%, and patient survival reached 98%, while patient retention exceeded 94%. Safety findings remained consistent with prior imlifidase studies, with no new tolerability concerns reported.
Mechanism of Action
Idefirix is approved in Europe as a desensitization therapy for highly sensitized adult kidney transplant patients with a positive crossmatch against a deceased donor. Highly sensitized patients carry pre-formed donor-specific antibodies that severely restrict access to compatible donor organs and increase the risk of transplant rejection.
Imlifidase is an IgG-cleaving enzyme derived from Streptococcus pyogenes. The therapy rapidly cleaves circulating IgG antibodies within hours, enabling transplantation in patients who would otherwise remain ineligible because of immunologic incompatibility.
Study Design and Scope
The PAES enrolled 51 highly sensitized patients across 22 transplant centers in 11 European countries and the UK. All patients received Idefirix pre-treatment to convert a positive crossmatch to negative before kidney transplantation from deceased donors.
Regulatory Path Ahead
Chief Executive Officer Renée Aguiar-Lucander said the findings validate the clinical benefit of Idefirix in a population with substantial unmet need and support plans to seek conversion from conditional to full European marketing authorization by the end of 2026.
Coordinating investigator Tomas Lorant of Uppsala University said the study further supports the role of imlifidase in expanding transplant access for highly sensitized patients who often remain on waiting lists indefinitely because of immunologic incompatibility.
Global Regulatory Status
Beyond Europe, Idefirix is approved in the UK, Australia, Israel, Switzerland, Norway, Iceland, and Liechtenstein. In the United States, the FDA has accepted the biologics license application for imlifidase and assigned a PDUFA target action date of December 19, 2026.
In parallel, Hansa has entered into an exclusive licensing agreement with SERB, granting commercialization rights to Idefirix across Europe, the UK, Switzerland, Norway, Liechtenstein, Iceland, and the Middle East and North Africa.
Full PAES results will be presented at an upcoming medical congress.
Reference
About the Writer
Disha Sanjay Jadhav (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.