Alofisel for Crohn’s Fistulas Receives EMA Recommendation for Marketing Authorization in EU

Alofisel for Crohn’s Fistulas Receives EMA Recommendation for Marketing Authorization in EU
TiGenix received a European Medicines Agency (EMA) recommendation for the marketing authorization of Alofisel (darvadstrocel, Cx601) as an advanced therapy medicinal product (ATMP) for the treatment of complex perianal fistulas in people with Crohn’s disease. Perianal fistulas occur when an abnormal opening develops between the rectum and the outside of the body. It can lead to incontinence and sepsis (infection in the blood). In Crohn’s disease, perianal fistulas develop as a consequence of patie
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