Ireland
--:--IST

← All drugs

Entyvio

Vedolizumab

An intravenous or injectable biological therapy used to treat ulcerative colitis and Crohn's disease.

Integrin receptor antagonist
Generic name
Vedolizumab
Brand name
Entyvio
Route
Intravenous, Subcutaneous
Marketed by
Takeda
FDA pharmacologic class
Integrin Receptor Antagonist; Integrin Receptor Antagonists
First FDA approval
20 May 2014

Where Vedolizumab is approved

All regulators →

Of the three regulators tracked here, the first to approve Vedolizumab was the US, on 20 May 2014. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
20 May 2014
Entyvio
BLA125476 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
22 May 2014
Entyvio
EMA product page
First centralised authorisation
CACanada (Health Canada)
29 Jan 2015
Entyvio
Notice of Compliance 16576
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Vedolizumab

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$236.6m
37,347 prescriptions in 2025 · Entyvio, ENTYVIO Pen
+9% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Vedolizumab works

All drug targets →
  • Integrin alpha-4/beta-7 inhibitor Inhibitor
    Target: Integrin alpha-4/beta-7
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Inflammatory bowel diseasePhase 3
  • PouchitisPhase 3
  • Sclerosing cholangitisPhase 3
  • HIV infectious diseasePhase 2
  • Acute graft versus host diseasePhase 2
  • ColitisPhase 2
  • Graft versus host diseasePhase 2
  • Diarrheal diseasePhase 1
  • MelanomaPhase 1
  • Type 1 diabetes mellitusEarly phase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1743087, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7437, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Vedolizumab

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Vedolizumab. 3 are current, and 2 of these recommend it for at least some patients.

AppraisalNICE recommendationPublishedStatus
Vedolizumab for treating chronic refractory pouchitis after surgery for ulcerative colitis (terminated appraisal)
NICE TA826
Terminated (no company submission)21 Sep 2022Current
Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy
NICE TA352
Optimised26 Aug 2015Current
Vedolizumab for treating moderately to severely active ulcerative colitis
NICE TA342
Recommended5 Jun 2015Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Vedolizumab

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 3 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Entyvio
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Vedolizumab

ATC code
L04AA33
ChEMBL
CHEMBL1743087
DrugBank
DB09033
CAS number
943609-66-3
FDA UNII
9RV78Q2002
Wikidata
Q7918002
Wikipedia
Vedolizumab

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Entyvio is used for

ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )

How it works

12.1 Mechanism of Action Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainl…

Related clinical trials recruiting now

Compare Entyvio with

Explore more

How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 11 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.