TiGenix submits MAA for Cx601

3 March 2016

Belgian biopharmaceutical company TiGenix (EXT: TIG) has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product Cx601, it has been announced.

The application was made following positive results from the pivotal ADMIRE-CD Phase III study in Crohn’s disease patients suffering from complex perianal fistulas.

Maria Pascual, vice president of regulatory affairs at TiGenix, said: “The submission of this application to the EMA represents another important achievement in TiGenix’s efforts to bring Cx601 to those Crohn’s disease patients who currently lack an effective treatment for this serious and debilitating condition.”

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