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EU Yes For TiGenix Marks Tenth ATMP Approval in Ten Years

 
• By Neena Brizmohun

TiGenix says its treatment for complex perianal fistulae in Crohn’s disease is the first allogeneic stem cell therapy to be approved under Europe’s centralized marketing authorization pathway.

Concept of national healthcare system - EU - European Union
TiGenix has received approval to market Alofisel across the EU

TiGenix's Alofisel (darvadstrocel) for treating complex perianal fistulae in Crohn’s disease has become the tenth advanced therapy medicinal product (ATMP) in ten years to be approved for sale across the EU. 

Alofisel, an EU-orphan designated drug, is also the first allogeneic stem cell therapy to be approved under Europe’s centralized marketing authorization pathway, says the Belgian firm, which is currently being...

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