TiGenix submits Day 120 Responses to EMA for Crohn`s disease drug

TiGenix has submitted its responses to the European Medicines Agency`s (EMA) Day 120 List of Questions for Cx601, its lead product candidate being developed for the treatment of complex perianal fistulas in patients with Crohn`s disease.

The company said that it has submitted its responses to the Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as part of the centralized review process of the Marketing Authorization Application (MAA) of Cx601 for the treatment of perianal fistula in Crohn`s disease patients, licensed to Takeda Pharmaceuticals International AG (“Takeda”) for its exclusive development and commercialization outside the US.

TiGenix expects to receive the EMA Day 180 List of Outstanding Issues in February 2017 and anticipates a decision from the EMA on Cx601 Marketing Approval during 2017 which, if approved, would trigger the payment by Takeda to TiGenix of Euro 15 million.

Dr. Maria Pascual, Vice President Regulatory Affairs and Corporate Quality of TiGenix commented: “The submission of the Day 120 responses restarts the clock and brings us one step closer to being able, together with our partner Takeda, to provide this very much needed treatment to patients with Crohn`s disease suffering from such a debilitating disease,” concluded Dr. Pascual.