Swedish biopharmaceutical company Hansa Biopharma AB (STO:HNSA) announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for imlifidase.

The FDA's filing review was completed on day 60, verifying that the submission is substantially complete and meets the requirements for a full evaluation.

The BLA submission for imlifidase is supported by the 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.

A key secondary endpoint, dialysis independence at 12 months, was also statistically significant in favour of imlifidase and the treatment was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the UK under the tradename IDEFIRIX for the desensitisation treatment of highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor.