Hansa Biopharma AB (HNSA.ST) on Wednesday announced positive topline results from the European post-authorization efficacy study of Idefirix in kidney transplant patients.
The study evaluated one-year graft failure-free survival and patient survival in highly sensitized patients who underwent HLA-incompatible kidney transplantation following desensitization treatment with Idefirix.
The company said the primary objective was met, with 90% of highly sensitized kidney transplant patients achieving one-year graft failure-free survival following Idefirix pre-treatment.
At one year, mean estimated glomerular filtration rate was 52.4 mL/min/1.73 m², graft survival was 92%, and patient survival was 98%.
Idefirix is conditionally approved in the European Union as a desensitization treatment for highly sensitized adult patients prior to kidney transplantation from deceased donors.
Hansa Biopharma said the post-authorization study requirement for Idefirix has been fulfilled, and it plans to seek full European Union approval by the end of 2026.
The drug is also under review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.
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