MedPath

Vedolizumab

Generic Name
Vedolizumab
Brand Names
Entyvio
Drug Type
Biotech
CAS Number
943609-66-3
Unique Ingredient Identifier
9RV78Q2002

Overview

Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation implicated in diseases like ulcerative colitis or Crohn's disease. α4β7 integrin facilitates the interaction between lymphocytes and gut endothelial cells through the α4β7 integrin-MAdCAM1 interaction, leading to the mobilization of lymphocytes and thus contributing to gastrointestinal inflammation. Integrins implicated in cell migration into the intestinal tract included α2β2, α4β1, and α4β7; however, the selective activity of vedolizumab against α4β7 integrin has been thought to contribute to its more favorable safety profile compared to its predecessor natalizumab, the first integrin receptor antagonist approved by the FDA. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter. Vedolizumab was developed by Takeda and approved by the FDA under the brand name ENTYVIO for the maintenance therapy of moderately to severely active Ulcerative Colitis and Crohn’s Disease in April and September 2023, respectively.

Indication

Vedolizumab is indicated for adult patients with moderately to severely active Ulcerative Colitis or Crohn’s disease.

Associated Conditions

  • Moderately to Severely Active Crohn's Disease
  • Moderately to Severely Active Ulcerative Colitis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/08
N/A
Completed
Second Affiliated Hospital of Wenzhou Medical University
2025/03/18
Phase 3
Recruiting
2025/03/13
N/A
Completed
Second Affiliated Hospital of Wenzhou Medical University
2025/03/04
N/A
AVAILABLE
2025/02/27
Phase 2
Recruiting
Odyssey Therapeutics
2025/02/24
Phase 2
Not yet recruiting
Shilpa Grover, MD, MPH
2025/02/07
Phase 2
Recruiting
City of Hope Medical Center
2024/11/15
N/A
Recruiting
Humanitas Clinical and Research Center
2024/10/17
Phase 2
Suspended
Therakos LLC
2024/10/03
Phase 4
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Takeda Pharmaceuticals America, Inc.
64764-107
SUBCUTANEOUS
108 mg in 0.68 mL
3/28/2024
Takeda Pharmaceuticals America, Inc.
64764-300
INTRAVENOUS
300 mg in 5 mL
3/28/2024
Takeda Pharmaceuticals America, Inc.
64764-108
SUBCUTANEOUS
108 mg in 0.68 mL
3/28/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
5/22/2014

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ENTYVIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 108MG/0.68ML
SIN16673P
INJECTION, SOLUTION
108mg/0.68mL
1/11/2023
ENTYVIO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL
SIN14950P
INJECTION, POWDER, FOR SOLUTION
300 mg/vial
2/12/2016

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ENTYVIO
takeda canada inc
02497867
Solution - Subcutaneous
108 MG / 0.68 ML
7/8/2020
ENTYVIO
takeda canada inc
02436841
Powder For Solution - Intravenous
300 MG / VIAL
4/21/2015
ENTYVIO
takeda canada inc
02497875
Solution - Subcutaneous
108 MG / 0.68 ML
11/20/2020

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
ENTYVIO 300 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
14923001IP
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
ENTYVIO 108 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA
114923005
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Commercialized
ENTYVIO 108 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA
114923002
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Diagnóstico Hospitalario
Not Commercialized
ENTYVIO 300 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
114923001
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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