Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®. Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.
On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis. Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.
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