Swedish immunomodulatory therapy company Hansa Biopharma AB (STO: HNSA) on Tuesday announced that the first commercial patient in Australia has received a living donor kidney transplant following treatment with imlifidase (Idefirix), in line with its Therapeutic Goods Administration approval.

Imlifidase is an IgG-cleaving enzyme designed to inhibit IgG-mediated immune responses within hours of administration. It holds conditional approval in the EU, Norway, Liechtenstein, Iceland and the UK, and is also authorised in Australia, Israel and Switzerland.

The drug's efficacy and safety have been evaluated in four phase 2 studies in the EU and US and a randomised phase 3 study in the US Hansa is gathering further evidence through an observational follow-up and a post-approval efficacy study. The US Food and Drug Administration has accepted a Biologics License Application, with a Prescription Drug User Fee Act action date of 19 December 2026.

Patient outcomes will be recorded in an Australian registry, with real-world data expected to support future scientific publications and deepen understanding of Idefirix in living donor transplantation. Idefirix is approved in Australia for desensitising highly sensitised adult kidney transplant candidates with a positive cross-match against a living or deceased donor.

Highly sensitised patients have donor specific antibodies that react broadly against human leukocyte antigens, increasing the risk of tissue damage and rejection. They face limited access to compatible organs, longer waiting times and higher mortality risk, and represent around 10–15% of transplant waiting lists in the US and Europe. Around 170,000 patients in the US and Europe are awaiting a kidney transplant.