Posted by Michael Wonder on 20 Dec 2025
Hansa Biopharma submits BLA to FDA for imlifidase in desensitisation for kidney transplantation
19 December 2025 - The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitised patients.
Hansa Biopharma today announced the submission of a biologics license application to the US FDA for imlifidase. The Company is requesting priority review of the biologics license application for the use of imlifidase in the desensitisation of highly sensitised adult patients undergoing deceased donor kidney transplantation.
