Takeda receives CHMP backing for EU approval of Crohn’s disease therapy

Takeda and TiGenix have received a recommendation for EU approval of Cx601, a new treatment for perianal fistulas in Crohn's disease.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending a marketing authorisation for the investigational compound, which is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn's disease.

Cx601 is the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe, and is intended for the treatment of fistulas that have shown an inadequate response to at least one conventional or biologic therapy.

The recommendation was based on data from TiGenix's phase III ADMIRE-CD trial, which demonstrated the significantly superior safety and efficacy performance of the new drug.

Dr Asit Parikh, head of Takeda's gastroenterology therapeutic area unit, said: "Today's positive CHMP opinion is a crucial step to bringing a new treatment option to patients with complex perianal fistulas in Crohn's disease."

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