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# FDA Approves Entyvio Subcutaneous Dosing
- URL: https://www.fdaweb.com/fda-approves-entyvio-subcutaneous-dosing/
- Published: 2023-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:59:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155439

FDA has approved a subcutaneous (SC) administration device (single-dose pre-filled pen) for Takeda’s Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis after induction therapy with Entyvio intravenous. The drug was originally approved in 2014 for treating adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease whose previous treatment with standard therapies have not resulted in an adequate response. 

The approval for the new administration route was based on data from the VISIBLE 1 study, which demonstrated that Entyvio SC can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients, the company says. “A statistically significant proportion of patients receiving Entyvio SC 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46% vs. 14%; p<0.001) at Week 52,” it adds.