The FDA accepted Takeda's application for an injectable version of its ulcerative colitis drug Entyvio.
If approved, vedolizumab — marketed as Entyvio — will be available in prefilled syringe and pen options.
Takeda based its application on its Visible 1 phase 3 study. In it, a significant proportion of patients treated with Entyvio achieved clinical remission compared to those receiving a placebo.
Takeda GI Business Unit senior vice president Uthra Sundaram said, "The availability of a subcutaneous option for maintenance therapy with vedolizumab, in addition to the currently approved intravenous formulation, would provide physicians and patients with greater flexibility on route of administration, if approved."