Hansa Biopharma announced that the Australian Therapeutic Goods Administration has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase. The use of Idefirix should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.

Idefirix was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. In July 2023 the Australian Therapeutic goods Administration ("TGA") included Idefirix (im lifidase) on the Australian Register of therapeutic Goods as desensitization treatment For highly sensitized adult kidney transplant candidates prior to kidney transplantation from a donor against whom there is a positive cross-match. This indication allows transplants from either living or deceased donor kidneys.

Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant. Once they are inactivated with imlifidase, there is a window of opportunity for the transplant to take place.

By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection. The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials. Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study.