IDEFIRIX (Hansa Biopharma (Australia) Pty Ltd)
Product name
IDEFIRIX
Date registered
Evaluation commenced
Decision date
Approval time
189 (255 working days)
Active ingredients
imlifidase
Registration type
NCE/NBE
Indication
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.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.