Takeda Reports Submission of NDA to MHLW for Vedolizumab SC to Treat Moderately to Severely Active Ulcerative Colitis in Japan

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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