Shots:

• The approval follows CCT-001 study assessing Entyvio (vedolizumab- 300 mg) vs PBO in 157 patients with moderately to severely active CD- along with an additional data from GEMINI 2 and 3 study assessing Entyvio (vedolizumab) vs PBO in 1-115 and 416 patients respectively
• The CCT-001 study results:  improvement in CDAI-70; improvement in CDAI-100 (26.6% vs. 16.7%) @60wks. remission CDAI score < 150 (41.7% vs 16.7%)
• Entyvio (vedolizumab- IV) is a gut-selective biologic inhibiting the binding of alpha4beta7 integrin to MAdCAM-1 but not to VCAM-1 and has received MHLW’s approval in Jul’18 for moderately to severely active ulcerative colitis in Japan

Ref: Takeda | Image:Takeda