The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes on the heels of a placebo-controlled Phase III study that demonstrated a significant increase in clinical remission rates from 14% to 46%.
Phase III Study Results and Approval
The positive results from the Phase III study provided a robust basis for the FDA’s approval, highlighting the efficacy of vedolizumab in improving clinical outcomes for patients with UC. The approval marks a significant advancement in the treatment options available for patients with this chronic inflammatory bowel disease.
Launch Plans and Ongoing Reviews
Takeda is planning to launch the subcutaneous injection of Entyvio in the US by the end of October, expanding access to this effective therapy for UC patients. In addition to this, the product is currently under review for its use in treating Crohn’s disease, following a filing submitted earlier this month. This ongoing review indicates Takeda’s commitment to broadening the application of vedolizumab to address a wider range of gastrointestinal conditions.-Fineline Info & Tech
