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.

Background

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

FDA Approved Products

ENTYVIO
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:SUBCUTANEOUS
Strength:108 mg in 0.68 mL
Approved: 2024/03/28
NDC:64764-107
ENTYVIO Pen
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:SUBCUTANEOUS
Strength:108 mg in 0.68 mL
Approved: 2024/03/28
NDC:64764-108
Entyvio
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:INTRAVENOUS
Strength:300 mg in 5 mL
Approved: 2024/03/28
NDC:64764-300

Singapore Approved Products

ENTYVIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 108MG/0.68ML
Manufacturer:Vetter Pharma Fertigung GmbH & Co. KG
Form:INJECTION, SOLUTION
Strength:108mg/0.68mL
Online:Yes
Approved: 2023/01/11
Approval:SIN16673P
ENTYVIO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL
Manufacturer:HOSPIRA INC., PATHEON ITALIA S.P.A, Takeda Pharmaceutical Company Ltd., Hikari plant
Form:INJECTION, POWDER, FOR SOLUTION
Strength:300 mg/vial
Online:Yes
Approved: 2016/02/12
Approval:SIN14950P

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