Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has announced the approval of subcutaneously administered Entyvio (vedolizumab) by the European Commission, the executive branch of the European Union, as a maintenance therapy for the treatment of moderate-to-severe Crohn’s Disease or Ulcerative Colitis in adults. The drug is currently the only maintenance therapy approved in Europe for the treatment of these inflammatory bowel diseases via both intravenous and subcutaneous administration.
Takeda’s Head of the GI Franchise for the Europe and Canada Business Unit Adam Zaeske stated, “We are delighted that the European Commission has approved the subcutaneous formulation of Entyvio. This allows physicians and adult patients to choose the delivery method that works best for each individual patient. Takeda’s commitment to treating gastrointestinal disease means that we are always looking to innovate to provide further therapeutic options to better meet the needs of the patients we serve.”
The approval of Entyvio follows the completion of the VISIBLE clinical trial program, which consisted of three phase 3 studies evaluating the efficacy and safety of subcutaneously-administered Entyvio as a maintenance therapy in over 1,000 adults with moderate-to-severe Crohn’s Disease or Ulcerative Colitis that had responded clinically to intravenously-administered Entyvio.
Two of the studies assessed the ability of the medication to maintain clinical disease remission for 52 weeks, while the third assessed the drug’s “long-term safety and efficacy.” The clinical response of patients was assessed using the scoring system of the Mayo clinic and the Crohn’s Disease Activity Index (CDAI).
Entyvio will be offered to IBD patients in Europe in a pre-filled pen or syringe for subcutaneous administration as a maintenance therapy (e.g. in patients that have already achieved clinical improvement). Vedolizumab, a humanized monoclonal antibody targeting the alpha-4-beta-7 integrin, limits the trafficking of potentially damaging populations of white blood cells to tissues of the gastrointestinal tract to reduce the gut inflammation characteristic of IBD.
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Ulcerative Colitis (UC) and Crohn’s Disease (CD) are autoimmune disorders characterized by chronic gastrointestinal inflammation that often cycles between periods of increased severity and latency. The conditions have distinct immunopathology and are thought to result from a combination of genetic and environmental influences.
Vedolizumab is also indicated for the treatment of adults with moderate-to-severe UC or CD that failed treatment with standard-of-care therapies or antibody inhibitors of the pro-inflammatory cytokine tumor necrosis factor (TNF) alpha.