Hansa Biopharma reports positive efficacy and safety results from Idefirix[®] European post authorization study in kidney transplantation:
https://www.hansabiopharma.com/media/press-releases/2026/hansa-biopharma-reports-positive-efficacy-and-safety-results-from-idefirix-european-post-authorization-study-in-kidney-transplantation/
· The 1-year graft failure-free survival was 90%, which is clinically meaningful and supports full marketing authorization submission
· Idefirix was generally well tolerated with a safety profile consistent with previous clinical trial experience
· Submission to EMA for conversion to full marketing authorization planned for Q4 2026
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Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "These positive results represent a significant milestone for Idefirix and for Hansa. The one‑year graft failure‑free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. With this post‑authorization requirement fulfilled, we look forward to submitting an application for conversion to full marketing authorization to the EMA by the end of 2026."
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https://www.hansabiopharma.com/media/press-releases/2026/hansa-biopharma-reports-positive-efficacy-and-safety-results-from-idefirix-european-post-authorization-study-in-kidney-transplantation/
· The 1-year graft failure-free survival was 90%, which is clinically meaningful and supports full marketing authorization submission
· Idefirix was generally well tolerated with a safety profile consistent with previous clinical trial experience
· Submission to EMA for conversion to full marketing authorization planned for Q4 2026
...
Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "These positive results represent a significant milestone for Idefirix and for Hansa. The one‑year graft failure‑free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. With this post‑authorization requirement fulfilled, we look forward to submitting an application for conversion to full marketing authorization to the EMA by the end of 2026."
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