• The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients
• Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response
• FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review

Hansa Biopharma AB,announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase. The Company is requesting priority review of the BLA for the use of imlifidase in the desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "The submission of our BLA to the FDA marks a pivotal milestone for Hansa Biopharma and for highly sensitized patients living with end-stage renal disease in the US. If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant that would otherwise be out of reach."

The BLA submission for imlifidase is supported by the highly statistically significant outcome of the pivotal US 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.

Upon determination of acceptance of the application for review, FDA will communicate a target action date under the Prescription Drug User Fee Act (PDUFA). Hansa has requested priority review for the BLA, which if granted would establish a six-month review cycle with a potential for an approval as early as Q3 2026.