Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Vedolizumab for Ulcerative Colitis
New Delhi: Intas Pharmaceuticals has got the go-ahead from the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial to compare the efficacy, safety, immunogenicity, and pharmacokinetics of the proposed biosimilar of Vedolizumab (INTP53) Intravenous Injection and Vedolizumab reference for induction and maintenance therapy in patients with moderate to severely active ulcerative colitis.
This came after Intas Pharmaceuticals presented the proposal for grant of permission to conduct a Phase III clinical trial as per the protocol titled “A Phase III, Randomized, Double-Blind, Multicenter, Active-Controlled, Two-Arm, Parallel Group Study to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics of the Proposed Biosimilar of Vedolizumab (INTP53) Intravenous Injection and Vedolizumab Reference for Induction and Maintenance Therapy in Patients with Moderate to Severe Active Ulcerative Colitis” vide protocol number: 0046-24 Version No.1.0, Dated 23-02-2024.
Vedolizumab is an integrin blocker and anti-inflammatory agent used to manage ulcerative colitis and Crohn's disease in adults. 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.
At the recent SEC meeting on gastroenterology and hepatology held on July 25, 2024, the expert panel reviewed the proposal for grant of permission to conduct a Phase III clinical trial protocol presented by the drug major Intas Pharmaceuticals.
After detailed deliberation, the committee recommended conducting the Phase III clinical trial as per the protocol presented by the firm.
