Hansa Biopharma AB has announced that the U.S. Food and Drug Administration has accepted its Biologics License Application (BLA) for imlifidase, marking a regulatory milestone for the company.

The FDA completed its 60-day filing review, confirming that the application is sufficiently complete and meets the requirements for a full regulatory evaluation. The company now awaits the formal 74-Day Letter from the agency, which will outline the review plan, timelines and other key procedural details.

Renée Aguiar-Lucander, Chief Executive Officer of Hansa Biopharma, said the company looks forward to engaging with the FDA during the review process in the coming months.

Imlifidase is a novel IgG-cleaving enzyme designed to rapidly inactivate more than 95 percent of donor-specific antibodies within two to six hours of administration. By reducing circulating antibodies, the therapy creates a critical window that enables HLA-incompatible kidney transplantation in highly sensitised patients who would otherwise face limited transplant options.

The BLA submission is supported by results from the pivotal U.S. Phase III ConfIdeS trial. The study evaluated 12-month kidney function in highly sensitised adult kidney transplant patients (cPRA ≥99.9 percent) with a positive crossmatch against a deceased donor, compared with a control arm.

The trial met its primary endpoint, demonstrating statistically significant improvement in kidney function at 12 months in the imlifidase arm, as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint—dialysis independence at 12 months—also showed statistical significance in favour of imlifidase (p = 0.0007). The therapy was generally well tolerated, with a safety profile consistent with previous clinical trial findings.

If approved, imlifidase could expand transplant access for highly sensitised patients by overcoming immunological barriers that limit compatibility with donor organs.