Posted by Michael Wonder on 28 Apr 2023
Takeda announces FDA acceptance of BLA resubmission for investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis
27 April 2023 - Takeda today announced that the US FDA)has accepted for review its biologics license application resubmission for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis after induction therapy with Entyvio intravenous.
The resubmission is intended to address FDA feedback in a December 2019 complete response letter.
