en.Wedoany.com Reported - Hansa Biopharma has announced positive top-line results from a post-approval efficacy study of Idefirix (imlifidase) in highly sensitized kidney transplant patients in Europe. The study addresses a significant unmet need in transplantation: highly sensitized patients have pre-formed donor-specific antibodies, making it difficult to find compatible donor organs, and some patients remain on transplant waiting lists for extended periods.

Idefirix received conditional approval in the EU for desensitization treatment in highly sensitized adult patients prior to receiving a deceased donor kidney transplant. As part of the conditional marketing authorization, the European Medicines Agency (EMA) required this post-approval efficacy study. The study was open-label and enrolled 51 patients across 22 transplant centers in 11 countries in the EU and the UK.

The primary endpoint was met: after converting a positive crossmatch to negative with Idefirix pretreatment, 90% of treated patients achieved one-year graft survival without failure. At one year, graft survival was 92%, patient survival was 98%, and the mean estimated glomerular filtration rate was 52.4 mL/min/1.73 m². Patient retention exceeded 94%, and Idefirix was generally well tolerated, with a safety profile consistent with prior clinical experience.

Hansa plans to submit an application to the EMA by the end of 2026 to convert Idefirix from conditional approval to full marketing authorization. If successful, these data could enhance clinical confidence and improve reimbursement discussions for treatment in this highly specialized transplant setting.

This article is compiled by Wedoany. All AI citations must indicate the source as "Wedoany". If there is any infringement or other issues, please notify us promptly, and we will modify or delete it accordingly. Email: news@wedoany.com