Hansa Biopharma AB has announced that the FDA has set December 19, 2026, as the Prescription Drug User Fee Act (PDUFA) action date for the company’s Biologics License Application (BLA) for imlifidase. If approved, imlifidase would become the first treatment specifically addressing highly sensitized patients awaiting kidney transplantation in the United States.
The PDUFA date assignment follows the FDA’s previous acceptance of the BLA for imlifidase, a potential new option for a patient population that currently has very limited access to kidney transplantation. Renée Aguiar-Lucander, CEO of Hansa Biopharma, said the PDUFA date marks an important milestone for both the company and highly sensitized patients in the U.S. who are waiting for a kidney transplant, adding that Hansa looks forward to working with the FDA as it completes its review in the coming months.
Highly sensitized patients represent an underserved subgroup in kidney transplantation, accounting for an estimated 10–15% of individuals on transplant waiting lists. These patients have high levels of pre-formed donor specific antibodies with broad reactivity against human leukocyte antigens, often resulting from previous transplants, blood transfusions, or pregnancies. Because these antibodies can trigger an immediate immune response against a donor organ, causing tissue damage and likely graft rejection, compatible donors are extremely difficult to identify, leading to significantly prolonged or even indefinite waiting times and long-term dependence on dialysis.
Imlifidase is already conditionally approved in the European Union, Norway, Lichtenstein, Iceland and the United Kingdom under the tradename IDEFIRIX for desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX is also approved in Australia and Switzerland.
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