FDA Approves Takeda’s Subcutaneous Entyvio Injection for Maintenance Therapy in Moderate to Severe Crohn’s Disease

1. The U.S. Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals' subcutaneous (SC) formulation of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn's disease.
2. The approval is based on the results of the Phase III VISIBLE 2 Study, which assessed the safety and efficacy of the SC formulation of Entyvio as maintenance therapy in adult patients with moderately to severely active Crohn's disease.
3. The primary endpoint of the study was clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score of ≤150 at Week 52.
4. The SC administration of Entyvio is available as a single-dose prefilled pen (ENTYVIO Pen), providing patients with flexibility and choice of route of administration.
5. In September 2023, the FDA also approved the SC administration of Entyvio as a maintenance treatment in adults with moderately to severely active ulcerative colitis.
6. The safety profile of the SC formulation of Entyvio was consistent with the intravenous (IV) formulation, with injection site reactions noted as an adverse reaction.
7. The approval of Entyvio SC for Crohn's disease offers patients the option to administer their maintenance treatment at home or on the go.