Takeda Pharmaceutical Co has submitted its gut-selective monoclonal antibody vedolizumab for approval in the USA for moderately to severely active Crohn's disease and ulcerative colitis, the two most common forms of inflammatory bowel disease.
The filing to the US Food and Drug Administration is based on four Phase III trials which studied 2,700 patients in nearly 40 countries, making it the largest late-stage clinical trial programme conducted to date simultaneously evaluating both CD and UC. The GEMINI programme investigated the drug in patients who had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or anti-tumour necrosis factor (TNF)-alpha therapy, such as AbbVie's Humira (adalimumab).
Vedolizumab is a novel alpha-4 beta-7 integrin antagonist which works by blocking a key inflammatory marker on white blood cells. Takeda acquired the drug with its $8.80 billion purchase of Millennium Pharmaceuticals in 2008 and a number of analysts believe the treatment, which was filed in Europe in March, has the potential to be a blockbuster.