Hansa Biopharma AB announces the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for imlifidase.
The company is requesting priority review of the BLA for the use of imlifidase in the desensitisation of highly sensitised 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 sensitised 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 sensitised patients to 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 III ConfIdeS trial, which evaluated 12-month kidney function in highly sensitised adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared with 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 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 6-month review cycle with a potential for approval as early as Q3 2026.