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Takeda submits MA application in EU for vedolizumab
Takeda has submitted a Marketing Authorization Application (MA) to the European Medicines Agency (EMA) for vedolizumab, an investigational humanised gut-selective monoclonal antibody for the treatment of Crohn's disease and moderate ulcerative colitis -severe, the two most common chronic inflammatory bowel diseases. If approved, vedolizumab could represent the first and only intestinal-selective biological agent currently on the market for these diseases.
Worldwide, nearly four million patients suffer from chronic inflammatory bowel disease. Of these, in the European Union, more than 500,000 are affected by ulcerative colitis and almost 230,000 by Crohn's disease. Both lead to inflammation of the lining of the digestive tract. While the inflammatory state produced by Crohn's can involve different areas of the digestive tract, ulcerative colitis exclusively affects the colorectal.
The two pathologies can be painful and debilitating, generate serious complications and significantly affect the quality of life of patients. "Ulcerative colitis and Crohn's disease are two debilitating chronic diseases with significant unmet medical needs, often affecting young people in their prime," said Asit Parikh, vice president, general medicine at Takeda.
We are encouraged by the results of Gemini, the vedolizumab phase 3 clinical development program, which involved approximately 3,000 patients in almost 40 countries, accrediting itself as the largest clinical trial program aimed at chronic inflammatory bowel diseases to date". The presentation of the AIC and was supported by the results of the phase 3 clinical studies, Gemini I, Gemini II, Gemini III and Gemini LTS (Long-term Safety, long-term safety), which are part of the Gemini Studies, a research program that provides four clinical trials aimed at evaluating the efficacy and safety of vedolizumab on clinical response and remission in patients with moderate to severe Crohn's disease and active ulcerative colitis who are unresponsive to at least one of the conventional therapies or to treatment with anti-Tnfα. "With its targeted mechanism of action - said Paul Rutgeerts, professor of Medicine at the Catholic University of Louvain, Belgium - vedolizumab is credited as a potential treatment option
