Evicenter
P&T meetings

Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
Last updated
85 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Limitations of current therapies

3 evidence topics · 5 sources

Summary

Existing desensitization approaches include apheresis and off-label medicines. These regimens may require repeated treatment over weeks or months and may not reduce antibodies sufficiently to permit transplantation. Compatible allocation and kidney exchange do not resolve access for every highly sensitized candidate; United States analyses identified persistent access limitations even after allocation priority. European guidance advises against leaving highly sensitized candidates on a kidney exchange list indefinitely when an incompatible transplant is a feasible option. Some practical recommendations for imlifidase-enabled transplantation remain based on evidence that expert authors describe as lacking high-level scientific support.