New Delhi:In a key regulatory development, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has approved the updated package insert for Vedolizumab 300 mg and 108 mg powder for concentrate for solution for infusion, marketed by Takeda Biopharmaceuticals India. The company had presented its proposal seeking approval for amendments in Section 4.6 (Use in Special Population) of the drug’s package insert, aligning it with the Company Core Data Sheet (CCDS) Version 9.0 Vedolizumab is an integrin blocker and anti-inflammatory agent used to manage ulcerative colitis and Crohn's disease in adults. 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. 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). After detailed deliberation, the committee recommended for approval of updated package insert for the proposed changes.
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