Hansa Biopharma AB announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix in adult patients with a positive crossmatch against an available organ from a diseased donor. The use of Idefirix in Switzerland is reserved for patients with a low probability of being transplanted within the framework of the current national kidney allocation system. Idefirix is the first and only medicine authorized for desensitization of highly sensitized patients prior to kidney transplantation, enabling these patients to better access a life-changing kidney transplantation from a deceased donor.

Highly sensitized kidney patients have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis. Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality, hospitalizations and additional costs. In 2021, there where 362 kidney transplantations in Switzerland, with 240 of those being from deceased donors.

The Marketing Authorization Application (MAA) in Switzerland was supported by data from four different Phase 2 open-label, single arm studies evaluating imlifidase in sensitized patients awaiting kidney transplantation.