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EU Approves Takeda’s Injectable Entyvio for IBD

EU OK Follows FDA’s Recent Rejection Of The New Formulation

 
• By Sten Stovall

Takeda has won EU approval for an injectable version of Entyvio to treat ulcerative colitis or Crohn’s disease, in contrast to the FDA’s rejection in December.

Digestive_System
Injectable Entyvio EU approval is for ulcerative colitis and Crohn’s disease • Source: Shutterstock

The European Commission has given regulatory approval for a new subcutaneous formulation of Takeda Pharmaceutical Co. Ltd.'s blockbuster gastrointestinal drug Entyvio (vedolizumab) as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease.

The decision, announced on 8 May, comes nearly five months after the US Food and Drug Administration knocked back the new formulation, on grounds the supporting filed data were insufficient...

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