Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

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

Hansa Biopharma AB has announced that it has submitted a Biologics License Application (BLA) to the US FDA for imlifidase, seeking priority review for its use in desensitizing highly sensitized adults awaiting deceased donor kidney transplants.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, called the submission a “pivotal milestone” for the company and patients.

She 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.”

The BLA is backed by data from the pivotal US Phase 3 ConfIdeS trial, which studied 12-month kidney function in highly sensitized patients (cPRA ≥99.9%) with a positive crossmatch against deceased donors.

The trial met its primary endpoint, showing significantly improved kidney function in patients treated with imlifidase, as measured by mean estimated glomerular filtration rate (eGFR).

If the FDA accepts the application and grants priority review, Hansa could see a decision within six months, potentially leading to approval as early as Q3 2026.