After receiving the US FDA’s feedback in a CRL in Dec 2019, the company has resubmitted a BLA for SC Entyvio (vedolizumab) as a maintenance therapy for patients with moderately to severely active UC post-induction therapy with IV Entyvio. Takeda expects a decision from the US FDA by the end of 2023
The 2019 CRL was not concerned about Entyvio’s IV formulation, its safety & efficacy data, or the data from the pivotal (VISIBLE 1) trial (based on which the BLA for Entyvio SC was previously submitted), thereby the resubmitted BLA includes additional data obtained to evaluate the use of SC Entyvio
The (VISIBLE 1) trial evaluated the safety & efficacy of SC Entyvio as maintenance therapy in patients (n=216) with UC who achieved CR at 6wks. following 2 doses of vedolizumab IV therapy at wks 0 & 2
Ref: Businesswire | Image: takeda
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