Takeda files for EU approval of gastrointestinal therapy

Takeda has submitted a marketing authorisation application to the European Medicines Agency for its gastrointestinal therapy vedolizumab.

The investigational gut-selective humanised monoclonal antibody is intended for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, the two most common types of inflammatory bowel disease.

If approved, it would become the first therapy of its type to be made available in Europe for the treatment of these conditions.

The submission is supported by data from the phase III Gemini trial programme, which demonstrated the efficacy and safety of vedolizumab in terms of clinical response and remission rates.

Dr Asit Parikh, vice-president of general medicine at Takeda, said: "We are encouraged by the findings of Gemini … which studied approximately 3,000 patients in nearly 40 countries, making it the largest IBD clinical trial program conducted to date."

Earlier this year, the company received US regulatory approval for Nesina, as well as fixed-dose combinations of Oseni and Kazano, for the treatment of type 2 diabetes.