Shots:

• The NDA filing is based on P-III VISIBLE 1 study results assessing Vedolizumab (SC- 108mg- q2w) as maintenance therapy vs PBO in 216 patients with mod. to sev. active UC following two doses of IV administration of vedolizumab (300 mg) as an induction therapy at 0 to 2 wks.
• P-III VISIBLE 1 study results: @52 wks. clinical remission (46.2% vs. 14.3%)- IV vedolizumab (42.6%); Injection-site reactions (10.4% vs 0%) with none leading to treatment discontinuation.  The results of the VISIBLE 1 trial were also presented at United European Gastroenterology Week Congress
• Entyvio (vedolizumab) is a gut-selective mAb- designed to specifically antagonize the α4β7 integrin to intestinal (MAdCAM-1) but not (VCAM-1) and is already approved as an IV formulation

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 Ref: Takeda | Image: Takeda