Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation
19 Dec 2025, 20:35
Regulatory information
PRESS RELEASE
The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients
Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response
FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review
.. Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “The submission of our BLA to the FDA marks a pivotal milestone for Hansa Biopharma and for highly sensitized patients living with end-stage renal disease in the US. If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant that would otherwise be out of reach. ..”
https://www.hansabiopharma.com/media/press-releases/2025/hansa-biopharma-submits-bla-to-fda-for-imlifidase-in-desensitization-for-kidney-transplantation/
19 Dec 2025, 20:35
Regulatory information
PRESS RELEASE
The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients
Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response
FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review
.. Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “The submission of our BLA to the FDA marks a pivotal milestone for Hansa Biopharma and for highly sensitized patients living with end-stage renal disease in the US. If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant that would otherwise be out of reach. ..”
https://www.hansabiopharma.com/media/press-releases/2025/hansa-biopharma-submits-bla-to-fda-for-imlifidase-in-desensitization-for-kidney-transplantation/
