Takeda’s Entyvio (vedolizumab) Receives MHLW’s Approval for Moderate to Severely Active Crohn’s Disease in Japan

Takeda’s Entyvio (vedolizumab) Receives MHLW’s Approval for Moderate to Severely Active Crohn's Disease in Japan

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

Click here to read full press release/ article | Ref: Takeda | Image: 3vent