Posted by Michael Wonder on 21 Jun 2017
Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients
19 June 2017 - Takeda and TiGenix today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for review the file on investigational compound Cx601 to treat complex perianal fistulas in patients with Crohn’s disease.
Filing follows Swissmedic granting orphan drug status for Cx601 in September 2016,1 which recognises the rare and debilitating nature of the disease. The marketing authorisation application for Cx601 is already under review for the same indication by the CHMP of the EMA.
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally administered for the treatment of complex perianal fistulas in patients with Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy.The Swissmedic filing submission included the Phase III ADMIRE-CD trial data for Cx601. The ADMIRE-CD trial is a randomised, double-blind, controlled, Phase III trial designed to investigate the efficacy and safety of investigational compound Cx601. 24 and 52 week data were included in the Swissmedic filing submission. The 24 week data were published in the Lancet and showed both the primary endpoint and the safety and efficacy profile were met.
