In addition to its reactivity to gut-associated lymphoid tissues, Act-1 antibody also stains large numbers of lymphocytes in rheumatoid synovium, and has been shown by Dr. A. A. Ansari of Emory University to prevent or delay onset of AIDS in a monkey-model of Simian Immunodeficiency Virus-induced AIDS. Thus, reactivity with this antibody may show widespread applicability in inflammatory processes of diverse etiologies. Society and culture
Legal status
Takeda filed a Marketing Authorization Application (MAA) in the European Union on 7 March 2013 and a Biologic License Application (BLA) with the U.S. Food and Drug Administration on 21 June 2013 for both Crohns disease and ulcerative colitis. On 4 September 2013, vedolizumab was given a Priority Review Status, which functions to expedite potential acceptance to market.In March 2014, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for vedolizumab (brand name Entyvio).In May 2014, vedolizumab (Entyvio) was approved by the FDA for treatment of both moderate-to-severe ulcerative colitis and moderate-to-severe Crohns disease. In May 2014, Entyvio was approved for medical use in the European Union. In April 2015, Health Canada approved Entyvio. Research
Vedolizumab eventually completed a number of phase III clinical trials for Crohns Disease and Ulcerative Colitis (GEMINI I, GEMINI II, and GEMINI III) that demonstrate that vedolizumab is an effective and well tolerated drug.
Vedolizumab, sold under the brand name Entyvio, is a monoclonal antibody medication developed by Millennium Pharmaceuticals, Inc. for the treatment of ulcerative colitis and Crohns disease. It binds to integrin α4β7 (LPAM-1, lymphocyte Peyers patch adhesion molecule 1, a dimer of Integrin alpha-4 and Integrin beta-7). Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity. Medical use
Ulcerative colitis and Crohns disease
Vedolizumab has been approved for use in adults with moderate to severe ulcerative colitis or Crohns disease having a poor response to tumor necrosis factor (TNF) blockers or corticosteroids, or for those who are steroid-dependent. Checkpoint inhibitor colitis
Vedolizumab may be used to treat steroid refractory checkpoint inhibitor induced colitis, if infliximab is ineffective or contraindicated. Clinical trials
Ulcerative colitis
Vedolizumab has been investigated in several studies in adult patients. and at least 6 have results reported|date=June 2020}} Patients with moderate to severe active disease in whom conventional therapy or TNF-alpha antagonists were ineffective or could not be tolerated received either vedolizumab or placebo. The main measure of effectiveness was the proportion of patients whose symptoms improved after six weeks of treatment. Vedolizumab was shown to be more effective than placebo: 47% (106 out of 225) of patients who received vedolizumab showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo. The study also showed that vedolizumab maintained the effect up to 52 weeks more effectively than placebo.