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Idefirix
Published
Product name
Idefirix
Active ingredient
Imlifidase
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Idefirix (imlifidase) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
Idefirix has provisional approval for the desensitisation treatment of highly sensitised adult kidney transplant candidates prior to kidney transplantation from a donor against whom there is a positive cross-match (see Section 5.1 Pharmacodynamic properties, Clinical trials). The use of Idefirix should be reserved for patients who are otherwise unlikely to receive a kidney transplant.
The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.
How this medicine works
Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that cleaves the heavy chains of all human IgG subclasses and IgG-type of B-cell receptor (BCR) but no other immunoglobulins. The cleavage of IgG leads to elimination of Fc-dependent effector functions, including complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC). By cleaving all IgG, imlifidase reduces the level of donor specific antibody (DSA), thus enabling transplantation.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Idefirix was considered favourable for the therapeutic use approved.