The FDA has approved the subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in adult patients with moderate-to-severe Crohn’s disease after induction therapy via IV administration. The approval was based on the results of a phase 3 clinical trial, VISIBLE 2, which showed that patients who received SC vedolizumab achieved higher rates of clinical remission compared to those who received a placebo. The safety profile of SC vedolizumab was consistent with previous findings, with common adverse events including injection site reactions. This approval provides patients with more options for managing Crohn’s disease and affirms the efficacy of Entyvio.
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Takeda’s Entyvio snags second FDA approval as ‘subcutaneous option’ for Crohn’s disease
