FDA acceptance of BLA resubmission for subcutaneous administration of Entyvio for maintenance therapy in moderately to severely active ulcerative colitis.- Takeda
Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous. The resubmission is intended to address FDA feedback in a December 2019 Complete Response Letter (CRL).
Since receiving the CRL Takeda has worked closely with the FDA to address the Agency’s feedback; this resubmission package includes additional data collected to investigate the use of subcutaneous administration of Entyvio. The contents of the letter were unrelated to the intravenous (IV) formulation of Entyvio, the clinical safety and efficacy data, and conclusions from the pivotal VISIBLE 1 trial supporting the Entyvio SC BLA.
VISIBLE 1 assessed the safety and efficacy of a SC formulation of Entyvio as maintenance therapy in 216 adult patients with moderately to severely active UC who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2.1 The primary endpoint was clinical remission at week 52, which was defined as a total Mayo score of less than 2 and no subscore greater than 1.1 ,Takeda expects a decision from the FDA by the end of 2023.
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