FDA Accepts Imlifidase BLA for Kidney Transplant Desensitization
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. A Prescription Drug User Fee Act target date of December 19, 2026 has been assigned to the application.
Imlifidase is a Streptococcus pyogenes-derived cysteine protease that rapidly degrades immunoglobulin G antibodies within 2 to 6 hours of administration. This process allows for safe human leukocyte antigen-incompatible transplantation by eliminating donor-specific antibodies.
The FDA's filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation.
The BLA is supported by data from the randomized, open-label, phase 3 ConfldeS trial (ClinicalTrials.gov Identifier: NCT04935177), which evaluated imlifidase in 64 highly sensitized (calculated panel reactive antibody [cPRA] ≥99.9%) kidney transplant adults with positive crossmatch against a deceased donor.
Study participants were randomly assigned to receive imlifidase intravenously or best available treatment (control; any combination of plasma exchange, intravenous immunoglobulin, anti-CD20 antibody, and eculizumab or remain on wait list for organ offer). The primary endpoint was the mean estimated glomerular filtration rate (eGFR) at 12 months.
Results showed patients treated with imlifidase experienced superior kidney function compared with those in the control arm at 12 months (eGFR: 51.5mL/min/1.73m2 vs 19.3mL/min/1.73m2; difference, 32.2 mL/min/1.73m2; P <.0001).
The study also met its secondary endpoint of dialysis independence at 12 months, demonstrating improvement with imlifidase (P =.0007). Notably, the trial had a patient retention rate of over 90%. The safety profile of imlifidase was consistent with previously reported studies.