Takeda's Entyvio (vedolizumab) Receives the US FDA’s Approval for Subcutaneous Administration to Treat Active Ulcerative Colitis
Shots:
- The US FDA has approved Entyvio (SC) for maintenance therapy in adults with moderately to severely active UC after induction therapy with Entyvio (IV). The therapy is expected to be available in the US as a single-dose pre-filled pen (ENTYVIO Pen) by the end of Oct
- The approval was based on the P-III study (VISIBLE 1) study evaluating Entyvio (SC) as maintenance therapy in 162 patients which showed that patients who received Entyvio SC (108mg, q2w) maintenance therapy achieved clinical remission (46% vs 14%) at 52wk. The safety profile was consistent with the known safety profile of Entyvio IV
- Vedolizumab IV received marketing authorization in 70+ countries, incl. the US & EU while the BLA for Entyvio (SC) is currently under the US FDA’s review for active Crohn’s disease
Ref: takeda | Image: takeda
Related News:- Takeda Reports BLA Resubmission to the US FDA for Entyvio as a Maintenance Therapy for Ulcerative Colitis
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
