Takeda wins FDA approval for self-administered, subcutaneous Entyvio in ulcerative colitis

The FDA has ap­proved a sub­cu­ta­neous ver­sion of Take­da’s ul­cer­a­tive col­i­tis drug En­tyvio, more than three years af­ter re­ject­ing the com­pa­ny’s ap­pli­ca­tion over what it said were is­sues re­lat­ed to the de­sign and la­bel­ing of the de­vice.

The drug will be avail­able as a sin­gle-dose pre-filled pen by the end of Oc­to­ber. It’s ap­proved for use af­ter in­duc­tion ther­a­py with in­tra­venous En­tyvio (vedolizum­ab), Take­da an­nounced Wednes­day.

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