Sub Q Entyvio Hits Speed Bump After US Complete Response

Queries ‘Unrelated’ To Clinical Data

23 Dec 2019

Questions from FDA may delay progress to US approval of Takeda's more convenient formulation of blockbuster Entyvio.

3d render illustration of human digestive system - front view — US Setback For SC Entyvio? • Source: Shutterstock

Takeda Pharmaceutical Co. Ltd. has received a Complete Response Letter from the US Food and Drug Administration (FDA) on a Biologics License Application for a new subcutaneous (SC) formulation of its blockbuster inflammatory bowel disease drug Entyvio (vedolizumab).

The Japanese firm is seeking approval of the alpha4beta7 integrin antagonist antibody as a maintenance therapy in adults with moderate...