Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA).
FDA’s filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation.
Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months.”
Imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates > 95% of donor-specific antibodies within 2–6 hours of administration, providing a crucial window to enable HLA-incompatible kidney transplantation.
The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. 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.
