Entyvio® is the commercial brand name of Vedolizumab for Injection, a humanized monoclonal antibody against α4β7 integrin developed by Takeda. It selectively blocks the binding of α4β7 integrin on lymphocytes to mucosal addressin cell adhesion molecule-1, inhibiting lymphocyte migration to gastrointestinal tract and reducing intestinal inflammatory response.
Main Indications
Treatment of adult patients with moderately to severely active ulcerative colitis who have inadequate response, loss of response or intolerance to conventional therapy or tumor necrosis factor inhibitors;
Treatment of adult patients with moderately to severely active Crohn’s disease who have inadequate response, loss of response or intolerance to conventional therapy or tumor necrosis factor inhibitors.
Clinical Research
Global pivotal phase III trials confirmed that vedolizumab induces and maintains clinical remission in patients with ulcerative colitis and Crohn’s disease, and improves endoscopic manifestations;
Long-term extension studies demonstrated durable clinical efficacy and a favorable safety profile during repeated intravenous infusion;
Regional clinical trials in Asian populations verified consistent therapeutic effects and comparable tolerability with global cohorts.
Common Side Effects
Severe but important risks: Infusion-related hypersensitivity reactions, progressive multifocal leukoencephalopathy, increased risk of serious infections;
Common mild adverse reactions: Nasopharyngitis, headache, arthralgia, nausea, fever, fatigue, upper respiratory tract infection.
Approval Status in China
Original drug Entyvio® (Vedolizumab for Injection) was officially approved for marketing in China in 2020, with the specification of 300mg per vial. It is currently a prescription drug included in China’s Category B medical insurance catalogue.
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