The European Medicines Agency issued a positive opinion on Takeda and TiGenix's Cx601, a complex perianal fistulas treatment for adults with non-active/mildly active luminal Crohn's disease.
Here's what you should know:
1. This is the first allogeneic stem cell therapy the EMA issued a positive opinion on.
2. The Committee for Advanced Therapy assessed the drug based on results from TiGenix's Phase III ADMIRE-CD randomized trial.
3. In the phase III trial, the drug was found to be statistically significant to the control group when it came to achieving combined remission. The rates and treatments of adverse events and the discontinuation rates were comparable between the Cx601 group and the control groups.
Barcelona, Spain-based Hospital Clinic of Barcelona's Head of Gastroenterology Julian Panés, MD, said, "Following today's news, physicians and surgeons in Europe can look forward to offering these Crohn's disease patients a novel and minimally invasive alternative treatment option in the future, which in clinical trials achieved higher combined remission and lower relapse rates than the current standard of care."