Takeda Pharmaceutical Co has filed vedolizumab, its investigational, gut-selective monoclonal antibody, in Europe for the treatment of moderately to severely active ulcerative colitis and Crohn's disease.
The submission was supported by four Phase III studies, which studied 3,000 patients in nearly 40 countries, making it the largest inflammatory bowel disease clinical trial programme conducted to date. The GEMINI programme investigated vedolizumab's clinical response and remission in moderately-to -severely active Crohn's and UC patients, who had failed at least one conventional or anti-tumour necrosis factor (TNF)-alpha therapy, such as AbbVie's Humira (adalimumab).
The anti-TNF drugs are effective but have been associated with infections and other serious complications, such as tuberculosis. If approved, vedolizumab would be the first and only gut-selective biologic agent for UC and Crohn's, the two most common types of IBD on the market.
Takeda quoted Paul Rutgeerts, professor of medicine at the Catholic University of Leuven, Belgium, as saying that "with a targeted mechanism of action, vedolizumab has clinical promise as a potential treatment option". He added that "while there is no known cure, there is a need for new Crohn's and UC treatment options, in an effort to provide patients with additional choices for managing their disease, reducing symptoms and achieving remission".
Nearly four million people worldwide are affected by IBD, and in the European Union UC affects more than 500,000 people, while the number of Crohn's sufferers is estimated at 230,000. Many analysts believe that vedolizumab does indeed fill a gap in the IBD market and could become a blockbuster.