Intas Pharmaceutical Gets CDSCO Panel Nod to study Vedolizumab Powder for Concentrate for Solution for Infusion
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase I clinical trial of Vedolizumab Powder for Concentrate for Solution for Infusion 300 mg/vial.
This came after the firm presented the proposal to conduct a Phase I clinical trial titled “A randomized, double-blind, three-treatment, balanced, single intravenous infusion dose, Phase I, parallel-group, bioequivalence study of biosimilar Vedolizumab (INTP 53) of Intas Pharmaceuticals Limited, India with Entyvio of Takeda Pharmaceuticals USA, Inc., USA and Entyvio of Takeda Pharma A/S, Denmark in normal, healthy, adult human male subjects” vide Protocol No. Version No. 3.0 dated 27 September 2024.
Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with MAdCAM-1.
Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with MAdCAM-1. Vedolizumab does not bind to or inhibit the function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).
At the recent SEC meeting for Gastroenterology and Hepatology held on 21 January 2025, the expert panel reviewed the proposal to conduct a Phase I clinical trial titled “A randomized, double-blind, three-treatment, balanced, single intravenous infusion dose, Phase I, parallel-group, bioequivalence study of biosimilar Vedolizumab (INTP 53) of Intas Pharmaceuticals Limited, India with Entyvio of Takeda Pharmaceuticals USA, Inc., USA and Entyvio of Takeda Pharma A/S, Denmark in normal, healthy, adult human male subjects”
After detailed deliberation, the committee recommended the approval to conduct the Phase I clinical trial as per the protocol presented by the firm.
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