FDA Accepts Hansa Biopharma's BLA for Imlifidase in Kidney Transplantation

Hansa Biopharma AB announced on February 18, 2026 that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). 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 CEO stated the company now looks forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months.

Imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates > 95% of donor-specific antibodies within 2–6 hours of administration, providing a crucial window to enable HLA-incompatible kidney transplantation.

The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. Phase 3 ConfIdeS trial, which evaluated 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared to a control arm. The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint—dialysis independence at 12 months—was also statistically significant in favor of imlifidase (p = 0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. The trial evaluated kidney function at 12 months in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with a control arm. A total of 25 U.S. sites participated in the trial, and the primary endpoint was kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rate). The total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway.

Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the UK under the tradename IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX is also approved in Australia and Switzerland. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.

IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

Information about the trial is available at ClinicalTrials.gov: NCT04935177. This information was submitted for publication at 19:53 CET on February 18, 2026.