Hansa Biopharma has announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for imlifidase.
Hansa Biopharma submitted the BLA to the FDA back in December, with the regulatory body completing the filing review in just 60 days, verifying that the submission is substantially complete and meets the requirements for a full evaluation.
Renée Aguiar-Lucander, CEO, Hansa Biopharma, said: "We now look forward to receiving the 74-Day Letter, which will provide details regarding the review plan, timelines and other pertinent information and start working with the FDA as they go through their review during the coming months."
Imlifidase is a unique IgG‑cleaving enzyme that rapidly inactivates > 95% of donor‑specific antibodies within 2-6 hours of administration, providing a crucial window to enable HLA‑incompatible kidney transplantation.
The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal US Phase III ConfIdeS trial, which evaluated 12-month kidney function in highly sensitised adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared to a control arm.
The trial met its primary endpoint, demonstrating a significant improvement in kidney function in the imlifidase group at 12 months, as indicated by the mean estimated glomerular filtration rate (eGFR).
Additionally, a key secondary endpoint—dialysis independence at 12 months—also showed a statistically significant result in favour of imlifidase.
Imlifidase was generally well tolerated and its safety profile remained consistent with previous clinical trial findings.