Takeda Resubmits Ulcerative Colitis Therapy Application

 Takeda (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio^® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous. The resubmission is intended to address FDA feedback in a December 2019 Complete Response Letter (CRL).

https://www.biospace.com/article/releases/takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-colitis/