Hansa Biopharma Treats First Commercial Kidney Transplant Patient in Australia With Imlifidase

Hansa Biopharma announced that the first commercial patient in Australia has received a living donor kidney transplant following treatment with imlifidase (Idefirix), consistent with the indication approved by Australia's Therapeutic Goods Administration, the company said August 18, 2026.¹ Imlifidase 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.

"This first commercial living donor transplant patient in Australia represents an important milestone for Hansa and for patients facing significant barriers to transplantation," said Renée Aguiar-Lucander, CEO of Hansa Biopharma, in a company press release.¹ "We look forward to continued collaboration with the Australian transplant community to build experience with Idefirix across both living and deceased donor transplantations."

Why do highly sensitized patients need a treatment like imlifidase?

Highly sensitized patients carry donor-specific antibodies (DSAs) with broad reactivity against human leukocyte antigens, which can cause tissue damage and transplant rejection, making it difficult to find a compatible donor organ. These patients spend longer than average on transplant waiting lists, and longer waiting times are associated with increased mortality risk. Across the United States and Europe, highly sensitized patients make up around 10-15% of transplant waiting lists, according to the company.¹ Kidney failure, or end-stage renal disease, affects nearly 2.5 million people worldwide, and approximately 170,000 kidney patients in the US and Europe are currently waiting for a transplant.¹

How does imlifidase work, and what recognition has it received?

Imlifidase is an antibody-cleaving enzyme derived from Streptococcus pyogenes that targets and cleaves immunoglobulin G (IgG) antibodies, including DSAs, inhibiting IgG-mediated immune response within hours of administration to enable transplantation that would otherwise be blocked by a positive crossmatch.¹ The therapy was reviewed under the European Medicines Agency's priority medicines program, which supports medicines that may offer a major therapeutic advantage over existing treatments.¹

What clinical evidence supports imlifidase's use?

Imlifidase's efficacy and safety were studied in 4 phase 2 single-arm studies in the EU and US, along with a randomized, controlled phase 3 trial in the US.¹ In the pivotal phase 2 study, imlifidase eliminated DSAs and enabled transplantation in a cohort of highly sensitized patients who would otherwise have been unlikely to receive a compatible organ.² Hansa is continuing to collect clinical evidence through an observational follow-up study and a post-approval efficacy study.¹

What is the drug's regulatory status in other markets?

Imlifidase holds conditional marketing approval in the European Union, Norway, Liechtenstein, Iceland, and the United Kingdom under the Idefirix brand name, and is also approved in Australia, Israel, and Switzerland.¹ In the US, FDA accepted Hansa's biologics license application (BLA) for imlifidase in February 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.¹ The BLA is supported by data from the phase 3 ConfIdeS trial (NCT04935177), which evaluated 12-month kidney function in 64 highly sensitized kidney transplant patients with a positive crossmatch against a deceased donor, compared with a control arm, and met its endpoint with a highly statistically significant outcome.³

What are the limitations?

The company’s announcement describes a single commercial patient case in Australia rather than a clinical trial result, and patient outcomes will be tracked through an Australian registry rather than a controlled study. US approval remains pending FDA review, with a decision not expected until December 2026.

References

1. Hansa Biopharma. Hansa Biopharma announces first commercial kidney transplant patient treated with Idefirix in Australia. Press release. Published August 18, 2026. Accessed August 18, 2026. https://www.hansabiopharma.com/media/press-releases/2026/hansa-biopharma-announces-first-commercial-kidney-transplant-patient-treated-with-idefirix-in-australia/
2. Jordan SC, Lorant T, Choi J, et al. IgG endopeptidase in highly sensitized patients undergoing transplantation. N Engl J Med. 2017;377(5):442-453. doi:10.1056/NEJMoa1612567
3. Hansa Biopharma. Hansa Biopharma's biologics license application (BLA) for imlifidase accepted by the FDA. Press release. Published February 18, 2026. Accessed August 18, 2026. https://www.hansabiopharma.com/media/press-releases/2026/hansa-biopharmas-biologics-license-application-bla-for-imlifidase-accepted-by-the-fda/