The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for a drug desensitising highly sensitised adult kidney transplant patients. 

Imlifidase, developed by biopharmaceutical company Hansa Pharma, is a unique IgG cleaving enzyme that rapidly inactivates over 95% of donor–specific antibodies within two to six hours of administration, providing a crucial window to enable HLA incompatible kidney transplantation. 

The BLA submission for imlifidase was supported by the statistically significant outcome of the pivotal US Phase III ConfIdeS trial, which evaluated 12-month kidney function in highly sensitised adult kidney transplant patients with a positive crossmatch against a deceased donor, compared to a control arm. 

The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR). Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience.  

“We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months,” commented Renée Aguiar-Lucander, CEO of Hansa Biopharma.