Takeda Pharmaceutical has received a Complete Response Letter from the US Food and Drug Administration (FDA) in response to the submission of its biologics license application (BLA) for the approval of an investigational subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in adults with moderate to severe ulcerative colitis (UC).

Takeda says it is assessing the details of the letter and is 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 a key trial supporting the BLA.

Intravenous (IV) Entyvio was approved by the FDA in 2014 for patients with moderate to severe UC and Crohn’s disease (CD). Entyvio IV has been granted marketing authorization in more than 60 countries, including the US and European Union. Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha-antagonist.

Source: Takeda