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news.Takeda Pharmaceutical Company and its wholly-owned subsidiary, Takeda Pharmaceuticals USA have submitted biologics license application (BLA) for vedolizumab to the US Food and Drug Administration (FDA).
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Vedolizumab is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).
The BLA submission has been supported by the Phase 3 clinical studies known as the GEMINI Studies, which investigates the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients.
Almost 2,700 patients in nearly 40 nations were enrolled for the clinical trials program, which includes GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety).
Patients enrolled were those who have already failed at least one conventional therapy, such as corticosteroids, immunomodulators and/or a TNF-a antagonist.
GEMINI LTS open-label, long-term safety study of vedolizumab is ongoing, and designed to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab administration.