FDA sets PDUFA action date for the BLA for Imlifidase for the desensitisation treatment of highly sensitised adult kidney transplant patients – Hansa Biopharma
Hansa Biopharma AB announced that the FDA has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been assigned a Prescription Drug User Fee Act (PDUFA) action date of 19 December 2026. Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “With the PDUFA date now set, we are one step closer to potentially offering imlifidase as a transformative therapy option for patients who today have very limited access to a life‑changing kidney transplant. It marks an important milestone for Hansa Biopharma and for highly sensitized patients in the U.S. awaiting kidney transplantation. We look forward to working with the FDA as they complete their review over the coming months.”
About highly sensitized patients awaiting kidney transplantation
Highly sensitized patients constitute a particularly underserved group in kidney transplantation, representing an estimated 10–15% of individuals on transplant waiting lists. These patients carry high levels of pre-formed donor specific antibodies (DSA) with broad reactivity against human leukocyte antigens (HLA), typically resulting from previous transplants, blood transfusions, or pregnancies. Consequently, they face a substantial immunological barrier to transplantation, as DSAs can trigger an immediate immune response against a donor organ, leading to tissue damage and likely graft rejection. Compatible donors are therefore exceedingly difficult to identify, and highly sensitized patients often endure significantly prolonged — and in some cases indefinite — waiting times, remaining dependent on long-term dialysis while awaiting a viable matched organ.
