Hansa Biopharma has treated the first commercial Australian living donor kidney transplant patient with Idefirix (imlifidase) following approval by the Therapeutic Goods Administration.

First commercial patient treated in Australia

The patient received a living donor kidney transplant after treatment with imlifidase, which is approved in Australia as a desensitization treatment for highly sensitized adult kidney transplant candidates who have a positive cross-match against a living or deceased donor.

Hansa said the treatment was administered in line with the indication approved by the TGA, marking the first commercial use of Idefirix in an Australian living donor kidney transplant.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: “This first commercial living donor transplant patient in Australia represents an important milestone for Hansa and for patients facing significant barriers to transplantation.”

Highly sensitized kidney transplant candidates can face difficulty finding a compatible donor because of antibodies that can react against donor tissue. Desensitization aims to reduce these antibodies and enable transplantation where a positive cross-match would otherwise present a barrier.

Idefirix is designed to rapidly reduce immunoglobulin G antibodies, allowing transplantation to proceed in selected highly sensitized patients.

Australian real-world data to be collected

Hansa said the patient’s outcomes will be documented through an established Australian registry.

The company added that data collected from real-world clinical use may contribute to future scientific publications and improve understanding of imlifidase use in living donor kidney transplantation.

The announcement also provides an early indication of how Idefirix is being used commercially in Australia following its regulatory approval, with Hansa looking to build experience across both living and deceased donor kidney transplantation.

Aguiar-Lucander added: “We look forward to continued collaboration with the Australian transplant community to build experience with Idefirix across both living and deceased donor transplantations.”

Idefirix approved for highly sensitized kidney transplant candidates

In Australia, Idefirix is approved for adult kidney transplant candidates who are highly sensitized and have a positive cross-match with a living or deceased donor.

The treatment is intended to address a specific transplantation challenge in patients for whom antibody incompatibility can prevent access to a suitable donor kidney.

The collection of registry data from commercial use could provide additional evidence on outcomes and the practical use of imlifidase in living donor transplantation as the treatment becomes available to more patients in Australia.