#USA #FDA Approval #Lund #Hansa Biopharma #imlifidase

Hansa Biopharma's Acceptance of Imlifidase BLA by the FDA

On February 18, 2026, Hansa Biopharma AB announced a major milestone: the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for imlifidase. This pivotal moment opens the door for further evaluation of imlifidase, a groundbreaking therapy designed to facilitate kidney transplantation for patients with high immunological sensitization.

CEO Renée Aguiar-Lucander expressed optimism, stating, "We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines, and other pertinent information, allowing us to collaborate with the FDA during their review process in the upcoming months." This documentation is critical as it represents FDA's initial verification that Hansa's submission meets the necessary criteria for comprehensive assessment.

What is Imlifidase?

Imlifidase is a unique IgG-cleaving enzyme with the remarkable capability to inactivate over 95% of donor-specific antibodies within 2 to 6 hours of administration. This quick action is crucial for enabling patients who are highly sensitized to receive kidneys from incompatible donors. By providing a therapeutic window for transplantation, it addresses a significant challenge faced by kidney transplant patients.

The BLA submission comes on the heels of positive results from the ConfIdeS trial, a Phase 3 study that explored kidney function in highly sensitized adult patients. The study concluded with compelling evidence that imlifidase substantially improved kidney function at the 12-month mark compared to a control group (p < 0.0001). Moreover, a secondary endpoint showed an increase in dialysis independence for the imlifidase group, evidencing its clinical efficacy (p = 0.0007). Furthermore, participants reported that imlifidase was generally well tolerated, aligning with earlier clinical trial experiences.

Insights into the ConfIdeS Trial

The ConfIdeS trial was a randomized, controlled study critical for assessing imlifidase’s full potential. Conducted at 25 sites across the U.S., it targeted an urgent area of need within the kidney transplant sphere: patients showing high sensitization levels (cPRA ≥99.9%) who had a positive crossmatch against a deceased donor. The trial's primary endpoint evaluated kidney graft function after one year by measuring mean estimated glomerular filtration rate (eGFR).

The study's design included long-term follow-up, a vital component agreed upon with the FDA as part of their accelerated approval process. Hansa Biopharma remains dedicated to providing additional clinical data through ongoing studies as they continue to push for broader acceptance and use of imlifidase.

Regulatory Progress in the EU and Beyond

Notably, Imlifidase has already received conditional approval in the European Union, along with other regions including Norway, Lichtenstein, Iceland, the UK, Australia, and Switzerland. Marketed under the brand name IDEFIRIX®, it offers a promising solution for patients needing a kidney transplant yet facing high immunological barriers.

A Broader Perspective on Kidney Failure

Kidney disease is a significant issue globally, with nearly 2.5 million individuals affected by End-Stage Renal Disease (ESRD). In the U.S. and Europe alone, there are around 170,000 patients waiting for kidney transplants. Transplantation is often the recommended course of treatment for ESRD, offering improved survival rates and quality of life over dialysis.

Conclusion

Hansa Biopharma's acceptance of the BLA for imlifidase signifies a hopeful advancement in the treatment landscape for kidney transplantation. As Hansa engages with the FDA for the next steps, the possibility of transforming the future of transplant procedures for highly sensitized patients moves closer to reality, promising new beginnings for countless individuals worldwide.

For more information about the clinical trial, visit ClinicalTrials.gov (NCT04935177).