Swiss Regulators to Consider Cx601 as a Treatment for Crohn’s-related Anal Fistulas

Swiss Regulators to Consider Cx601 as a Treatment for Crohn’s-related Anal Fistulas
Swiss regulators have agreed to review Cx601 as a treatment for Crohn's-disease-related skin sores known as complex perianal fistulas. The Swiss Agency for Therapeutic Products, or Swissmedic, granted orphan drug status to the stem cell therapy in September 2016 — recognition that better treatments are needed for the rare, debilitating condition. The European Medicine Agency's Committee for Medicinal Products for Human Use is also reviewing Cx601 for Crohn's-related fistulas. A committee approval would lead to the European Commission making a final decision on authorization. An anal fistula is a small channel that develops between the end of the bowel and skin near the anus. It can can cause bleeding when a person defecates, and be painful. Leuven, Belgium-based TiGenix developed Cx601, but Takeda Pharma has the rights to it outside the United States. TiGenix develops stem cell treatments. A key focus of Takeda, based in Osaka, Japan, is developing therapies for gastrointestinal diseases. Takeda used 24- and 52-week results of the ADMIRE-CD Phase 3 clinical trial (NCT01541579) to support its request for Swissmedic to approve Cx601. The trial is assessing donated stem cells' effectiveness against anal fistulas at 24 weeks and during a follow-up period of up to 104 weeks. Researchers discussed the 24-week results of the trial in a Lancet article titled “Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial.” Cx601 stem cells proved to be a safe and effective treatment for fistulas in Crohn's patients who failed to respond to other treatments, both standard and biological, researchers said. The therapy is derive
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