Swedish biopharmaceutical company Hansa Biopharma AB (STO:HNSA) announced on Friday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for imlifidase.

The company is seeking priority review of the BLA for the use of imlifidase in the desensitisation of highly sensitised adult patients undergoing deceased donor kidney transplantation.

Hansa said that the submission is supported by the highly statistically significant outcome of the pivotal US Phase 3 ConfIdeS trial, which evaluated 12-month kidney function in highly sensitised adult kidney transplant patients (cPRA greater than or equal to 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 favour 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, the FDA will set 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.