The totality of data applicable to the EU marketing authorization, including the results of ADMIRE-CD II study, indicates that the clinical benefit of Alofisel is no longer demonstrated to justify its continued use in the EU and therefore, it would not outweigh the risks associated with its use. 

The safety profile for Alofisel in ADMIRE CD-II study was consistent with prior studies, as no new, emerging safety signals were identified.

Alofisel is therefore being withdrawn from the European Union (EU) market and no new patients should be treated in the EU/EEA with Alofisel after the 13 December 2024.