The FDA has approved a subcutaneous version of vedolizumab (Entyvio, Takeda) for maintenance therapy in adults with moderate to severe ulcerative colitis following induction therapy with IV vedolizumab. The biologic is expected to be available in the United States by the end of October in the form of a single-dose prefilled pen, according to the company.
The approval of this new route of administration for vedolizumab is based on the phase 3, randomized, double-blind, placebo-controlled VISIBLE