Posted by Michael Wonder on 24 Dec 2019
Takeda receives complete response letter from U.S. FDA for the investigational subcutaneous formulation of Entyvio (vedolizumab) as a maintenance therapy in adults with moderate to severe ulcerative colitis
20 December 2019 - Takeda today announced that it has received a complete response letter from the U.S. FDA in response to the submission of a biologics license application for the approval of an investigational subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in adults with moderate to severe ulcerative colitis (UC).
Takeda is assessing the details of the letter, gathering information needed to resolve the FDA’s questions, and will work closely with the FDA on a path to approval.
In its letter, the FDA posed questions unrelated to the clinical data and conclusions from the pivotal trial supporting the application.
