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Sub Q Entyvio Hits Speed Bump After US Complete Response

Queries ‘Unrelated’ To Clinical Data

 
• By Ian Haydock

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 to severe ulcerative colitis. But the US regulator has now...

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