The Swiss Agency for Therapeutic Products (Swissmedic) has accepted a review of Takeda and TiGenix’s file on investigational compound Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease.
Cx601 is a local administration of allogeneic expanded adipose-derived stem cells (eASC) to treat complex perianal fistulas in patients with Crohn's disease, who have had an inadequate response to at least one conventional or biologic therapy.
Last year, European cell therapy company TiGenix entered a licensing agreement to provide Japan’s drugmaker Takeda with the exclusive right to develop and market Cx601 for complex perianal fistulas outside the US.
Crohn's disease is a chronic inflammatory disease occurring in the gastrointestinal tract, while complex perianal fistulas are a complication for patients with Crohn's disease.
To date, perianal fistulas remain challenging for clinical treatment and are believed to be one of the most disabling manifestations of Crohn's disease.
The filing submission by Takeda included the Phase III data of the randomised, double-blind, controlled ADMIRE-CD trial that has been designed to assess the efficacy and safety of Cx601.
Takeda Pharma Switzerland general manager Julie Puype said: “Cx601 may have the potential to offer an alternative treatment option to current therapies, which are often associated with complications and a high failure rate for a disease that is difficult to treat and often leads to pain, swelling, infection and incontinence.
“The submission to Swissmedic is a key milestone in the commercialisation of Cx601 and reflects Takeda's continued commitment to delivering innovative, therapeutic options for patients with gastrointestinal diseases.”
In September last year, Swissmedic granted orphan drug status for Cx601, which recognises the rare and destroying nature of the disease.
Marketing authorisation application (MAA) for the treatment is currently under review for the same indication by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).