Hansa Biopharma advances transplant drug Idefirix toward full EU approval by 2026

A breakthrough study and a €110M partnership could redefine transplant care. How Idefirix's 98% patient survival rate is changing the game.

, and Administrator

2026 May 30 . 8:01 PM

1 min read

The image shows a poster with text that reads "More than 90% of people who have kidney disease... — The image shows a poster with text that reads "More than 90% of people who have kidney disease don't know they have it" and a logo at the bottom. The poster is likely meant to raise awareness of the prevalence of kidney disease and the need to take action to prevent it.

Hansa Biopharma advances transplant drug Idefirix toward full EU approval by 2026

Hansa Biopharma has announced plans to seek full marketing approval for its transplant drug Idefirix by late 2026. This follows successful results from a key study requested by European regulators. The company also secured a major commercial deal with SERB Pharmaceuticals for the drug’s distribution in several regions. The drug’s performance was tested in a post-authorisation efficacy study (PAES) involving 51 patients across 22 transplant centres in 11 European and UK countries. After one year, 90% of patients achieved graft failure-free survival, while overall graft survival reached 92% and patient survival stood at 98%. The mean estimated glomerular filtration rate—a measure of kidney function—was 52.4 mL/min/1.73 m² at the same point.

The trial met its primary goal, confirming Idefirix was generally well tolerated with a steady safety profile. These findings fulfilled a requirement set by the European Medicines Agency (EMA), marking both a regulatory milestone and a commercial boost for Hansa. Moving forward, SERB will oversee the long-term follow-up of the post-authorisation study. In a separate agreement, Hansa transferred commercial rights for Idefirix in Europe, the Middle East, and North Africa to SERB Pharmaceuticals. The deal includes an upfront payment of €110 million, with the potential for an additional €5 million based on future conditions.

The study results support Hansa’s plan to file for full marketing authorisation of Idefirix by the end of 2026. SERB will now manage the drug’s long-term monitoring and distribution in key regions. The data and commercial deal position Idefirix as a significant option in transplant care.