#Sweden #Lund #kidney transplant #Hansa Biopharma #imlifidase

Hansa Biopharma Submits BLA to FDA for Imlifidase

Hansa Biopharma AB, a biopharmaceutical company based in Sweden, has made a significant move by submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) concerning its innovative therapy, Imlifidase. This application specifically targets the desensitization of highly sensitized adults preparing for kidney transplants from deceased donors, marking a crucial development for patients suffering from end-stage renal disease.

Transformative Potential

The BLA submission is underpinned by the positive results from the pivotal Phase 3 ConfIdeS trial, which investigated Imlifidase's efficacy in enhancing kidney function among patients with a calculated Panel Reactive Antibody (cPRA) of 99.9% or higher—a significant hurdle for potential transplant candidates. The trial concluded that patients receiving Imlifidase displayed noteworthy improvements in their kidney function after 12 months, with statistical significance underscored by a p-value of less than 0.0001. Furthermore, the trial highlighted a significant secondary endpoint of achieving dialysis independence, also strongly favoring the Imlifidase group.

Renée Aguiar-Lucander, CEO of Hansa Biopharma, expressed optimism regarding the BLA, stating it represents a pivotal moment not just for the company but also for patients who are often excluded from transplant opportunities due to their high sensitization. Should the FDA grant approval, it is anticipated that Imlifidase could significantly alter the landscape of kidney transplants, offering new hope to patients who have faced previous rejection in access to transplant procedures.

The ConfIdeS Trial

The ConfIdeS trial was extensive, involving 64 highly sensitized adult patients across 25 sites in the U.S. Patients were randomized to either receive treatment with Imlifidase or be placed in a control group. The primary objective was to assess kidney graft function after one year, using mean estimated glomerular filtration rate (eGFR) as a measurement. This innovative enzyme works by cleaving immunoglobulin G (IgG) antibodies that can trigger immune responses against donor organs, thereby improving transplant compatibility.

The safety profile of Imlifidase—a key concern for any new therapy—was consistent with prior studies and was generally well-tolerated among participants. As with all applications submitted to regulatory bodies, the FDA will announce a target date for action under the Prescription Drug User Fee Act (PDUFA) following the receipt of the BLA.

Fast-Track Review

Hansa Biopharma has requested priority review status from the FDA, in hopes of expediting the approval process. If granted, this would mean a review timeframe of six months, potentially leading to approval as early as the third quarter of 2026. The anticipation surrounding this timeline reflects the urgent need for effective treatments for the millions facing kidney disease globally.

In the broader context, kidney disease remains a pressing public health issue, with approximately 170,000 patients in the U.S. and Europe awaiting kidney transplants. A successful therapy like Imlifidase could not only save lives but also significantly enhance the quality of life for those who might otherwise face a grim future on dialysis.

Conclusion

Hansa Biopharma's advance in the biopharmaceutical landscape with Imlifidase serves as a beacon of hope for those with severely limited transplant options. With a strong backing from clinical trials and a mission centered on rare immunological conditions, Hansa's developments are eagerly awaited by both healthcare professionals and patients alike. As the FDA reviews this groundbreaking application, the medical community remains attentive to the potential for Imlifidase to redefine successful kidney transplantation for sensitized patients.