FDA Accepts Hansa Biopharma’s Application for Imlifidase to Aid Highly Sensitized Kidney Transplant Patients

The U.S. Food and Drug Administration (FDA) has accepted Hansa Biopharma’s Biologics License Application (BLA) for imlifidase, a treatment designed to address highly sensitized kidney transplant patients. The FDA’s acceptance of the application marks a significant step in the regulatory process for the therapy, which aims to improve access to kidney transplants for patients who face challenges due to pre-existing antibodies.

Imlifidase is an enzyme-based therapy that targets and cleaves IgG antibodies, potentially enabling successful organ transplantation in patients with high levels of donor-specific antibodies. According to Hansa Biopharma, this group of patients often struggles to find compatible donors due to their sensitization status. The FDA will now review the submitted data as part of its evaluation process. Further updates regarding the timeline or next steps in the approval process have not yet been disclosed.

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Date: February 18, 2026

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GOAI