The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous Entyvio. Additionally, the single-dose prefilled pen formulation has also been approved for the treatment of moderately to severely active ulcerative colitis (UC) in the United States.
The FDA’s decision is supported by the positive outcomes of a Phase III clinical study, which successfully met its primary endpoint. The study demonstrated long-term clinical remission, with 48% of patients in the experimental group achieving this milestone, significantly higher than the 34% observed in the control group.-Fineline Info & Tech
