▎WuXiEdited by Kant Content Team

Recently, Takeda (Takeda) announced,The U.S. FDA has approved Entyvio (vedolizumab) subcutaneous injection for the maintenance treatment of adult patients with moderately to severely active Crohn's disease (CD) following induction therapy with the intravenous formulation of Entyvio.

Crohn's disease is the most common inflammatoryOne of the inflammatory bowel diseases (IBD). This approval was primarily based on data from the pivotal Phase 3 clinical trial VISIBLE2. The trial enrolled 409 adult patients with moderate to severe active Crohn’s disease (CD), who received two doses of open-label Entyvio intravenous infusion at Week 0 and Week 2.After treatment, clinical remission was achieved at week 6. Here, clinical remission is defined as a decrease of ≥70 points in the Crohn's Disease Activity Index (CDAI) score from baseline (week 0). The trial aimed to evaluate the safety and efficacy of the Entyvio subcutaneous formulation as maintenance therapy compared with placebo. Patients were randomly assigned in a 2:1 ratio to receive either 108 mg of Entyvio subcutaneous formulation every two weeks or placebo. Eligible patients had an inadequate response or intolerance to corticosteroids, immunomodulators, and/or anti-tumor necrosis factor (TNF) therapy. The primary endpoint was the clinical remission rate at week 52 (defined as a CDAI score ≤150).

The results showed that, at Week 52,Compared with placebo, the clinical remission rate significantly increased in patients receiving Entyvio subcutaneous injection, reaching 48.0% (132/275), compared to 34.3% (46/134) in the placebo group, p=0.008, achieving the primary endpoint of the study.The safety profile of the Entyvio subcutaneous injection formulation is generally consistent with the known safety profile of the intravenous formulation, but with an increased incidence of injection site reactions (including erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria, and edema at the injection site).

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Entyvio is a humanized monoclonal antibody drug. As a gut-selective biologic, it specifically antagonizes the α4β7 integrin., inhibiting its binding to mucosal addressin cell adhesion molecule 1 (MAdCAM-1) on intestinal mucosal cells, but not inhibiting its binding to vascular cell adhesion molecule 1 (VCAM-1). α4β7 integrin is expressed on the surface of some circulating leukocytes, which have been shown to play a role in mediating inflammation in certain inflammatory bowel diseases (IBD). MAdCAM-1 is preferentially expressed on the blood vessels and lymph nodes of the gastrointestinal tract. By antagonizing α4β7 integrin, Entyvio may limit the ability of certain leukocytes to infiltrate intestinal tissue. The subcutaneous injection formulation of Entyvio has been approved for marketing in the EU and over 50 other countries and regions. The intravenous injection formulation of Entyvio has received marketing authorization in more than 70 countries and regions, including the United States and the EU.