The provisional approval comes with a duration of two years. It is based on the data from Phase II studies that enrolled highly sensitised patients who received imlifidase before a kidney transplant from either living (17%) or deceased donors (83%).
University of Sydney clinical professor Kate Wyburn said: “Innovation in kidney transplantation has been quite limited for highly sensitised patients.
“With the approval of this new desensitisation treatment in Australia, we now have an opportunity to potentially help these immunologically complex patients who may otherwise never receive a transplant offer.”
An antibody-cleaving enzyme, Imlifidase is claimed to offer new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).
High levels of these preformed antibodies are found in the highly sensitised patients, and these can attach to the donor organ and damage the transplant.
Once the patients are inactivated with imlifidase, a window of opportunity is created for the transplant to happen.
By the time the body begins to synthesize new IgG, patients will get post-transplant immunosuppressive therapy to cut down the risk of organ rejection.
Hansa Biopharma president and CEO Søren Tulstrup said: “With nearly 28% of kidney transplant candidates in Australia considered highly sensitised, the approval of Idefirix represents an important innovation in kidney transplantation care for patients and clinicians.
“Hansa applauds the TGA for being the first regulatory body to approve the use of Idefirix in transplants from both living and deceased donors, thus ensuring comprehensive access for highly sensitised patients in Australia to this important therapy.”
In 2021 in Australia, a total of 875 kidney transplantations were performed among whom 202 (24%) were from living donors and 644 (76%) were from deceased donors.
Hansa seeks to obtain full approval for Idefirix from Australia’s TGA and requires further safety and efficacy data from the currently ongoing studies.