TiGenix has received the Day 180 List of Outstanding Issues (LoOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and expects to receive a Marketing Authorization decision for Crohn’s disease drug Cx601 in 2017.
Cx601 has been licensed to Takeda for the exclusive development and commercialization outside the US and receipt of the Marketing Authorization (MA) will trigger a milestone payment from Takeda to TiGenix of Euro 15 million.
The company said that after reviewing the LoOI, it is confident in its ability to provide detailed and clarifying responses to the CHMP and remains on track to receive a MA decision for Cx601 in 2017.
Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract, which is thought to affect up to 1.6 million people in Europe. Complex perianal fistulas are a complication for people living with Crohn’s disease and there are limited treatment options.