Key Points:
- The U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) version of Takeda’s Entyvio for adults with moderate to severe Crohn’s disease, following its previous approval for ulcerative colitis in September 2023.
- Patients who have completed an induction phase with intravenous (IV) Entyvio can now continue their maintenance therapy with the SC formulation, which is administered via a single-dose, pre-filled pen, providing convenience and flexibility for at-home or on-the-go treatment.
- The approval is supported by the results from the Visible 2 study, a Phase 3 trial that demonstrated a statistically significant proportion of patients on SC Entyvio achieving long-term clinical remission every two weeks, compared to those receiving a placebo.
- Common adverse reactions observed in the trial included nasopharyngitis, headache, arthralgia, and nausea.