ENTYVIO (vedolizumab), an integrin receptor antagonist, is a humanized IgG1 monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α4β7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons
|
PARAMETER |
DATA |
|
Manufacturer |
Takeda Pharmaceuticals U.S.A., Inc. |
|
Indication |
ENTYVIO is an integrin receptor antagonist indicated for moderately to severely active:
|
|
Cell Substrate |
Recombinant humanized IgG1 monoclonal antibody to the human α4β7 integrin. |
|
Manufacturing platform |
manufactured using recombinant Chinese hamster ovary (CHO) cells that secrete the antibody into the culture medium. The inoculum expansion starts with the thawing of one Working Cell Bank (WCB) ampoule followed by culturing the cells at increasing volumes and, finally, into the production bioreactor. Vedolizumab antibody is harvested from the production bioreactor. |
|
Dose in vial/final container |
300 mg of lyophilized vedolizumab in a single-use 20 mL vial. |
|
Dose to patient |
300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter. |
CLINICAL TRIALS
|
NCT |
TRIAL PHASE |
NO OF PATIENTS ENROLLED |
TITLE |
COUNTRIES |
|
NCT00619489 |
2 |
72 |
Long Term Safety of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease |
Canada |
|
NCT00783692 |
3 |
1116 |
Study of Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn's Disease (GEMINI II) |
United States, Canada, Puerto Rico |
|
NCT00790933 |
3 |
2243 |
United States, Australia, Belgium, Canada, Israel, Czechia, Germany, Korea, Republic of, Malaysia |
|
US pre-BLA |
November 13, 2012 |
|
US Approval |
May 20, 2014 |
|
EU Approval |
May 22, 2014 |
|
Health Canada Approval |
May 19, 2016 |
|
Japanese Ministry of Health, Labor and Welfare (MHLW) Approval |
May 22, 2019 |
|
TGA |
November 17, 2014 |
A Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee to evaluate the safety and efficacy of intravenous vedolizumab for the induction and maintenance of ulcerative colitis and Crohn’s disease and the post-market risk management strategy was held on December 9, 2013.