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Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) version of Entyvio, its treatment for adults with moderate to severe Crohn’s disease (CD).
Announced on April 18, the approval is based on the VISIBLE 2 trial and comes less than 7 months after the approval of SC vedolizumab in ulcerative colitis.
19.04.2024 - Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) ... Seite 1
Subcutaneous administration of vedolizumab is now approved for maintenance therapy in adults with moderate to severe active Crohn's disease after induction therapy with intravenous vedolizumab.
The primary endpoint of the study was clinical remission at week 52 with vedolizumab