First patient treated in the post-authorization efficacy study (PAES) of Idefirix (imlifidase) in highly sensitized kidney transplant patients.

This open-label Phase III study will enroll 50 highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor to confirm the long-term efficacy and safety of Idefirix. The PAES is an obligation under the conditional marketing authorization for Idefirix granted by EMA in August 2020, in order to complete a full marketing authorization for the European Union.

“Idefirix is the first and only treatment approved to enable kidney transplantation for highly sensitized patients that provides patients access to an effective, rapid and predictable desensitization treatment whose only option is an incompatible deceased kidney organ,” says Christian Kjellman, Chief Scientific Officer at Hansa Biopharma. “This truly international European study will help centers accommodate Idefirix-enabled transplantation, alongside our launch under conditional approval, as Idefirix becomes increasingly available to patients across Europe following positive reimbursement decisions in the region.”

The PAES will enrol patients across multiple countries and centers in Europe and the study will include 50 highly sensitized and crossmatch positive patients to be treated with Idefirix. The aim of the study is to confirm the long-term efficacy and safety of Idefirix and the primary objective of the study is to determine the 1-year graft failure-free survival of the Idefirix treated and transplanted patients. In addition, a total of 50-100 patients undergoing compatible kidney transplantation at the participating centers will be included and serve as a non-comparative concurrent reference cohort, with no formal comparison, to contextualize the 1-year graft failure-free survival of the Idefirix treated patients.

“As of 2022, 10-15% of all of kidney patients on waiting lists in the U.S. and Europe are considered highly sensitized,” says Vincenza Nigro, Kidney Transplant Franchise Lead at Hansa Biopharma. “Although allocation systems and prioritization programs have improved access to transplantation for highly sensitized kidney patients, many are still disadvantaged and in urgent need of more personalized and innovative options. We must keep striving for equity to address the medical needs of all, including highly sensitized kidney patients, no matter the challenges.”