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Takeda Reports FDA's Acceptance of BLA for Entyvio (Vedolizumab SC) as a Maintenance Therapy in Moderate to Severe Active Ulcerative Colitis

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Takeda Reports FDA's Acceptance of BLA for Entyvio (Vedolizumab SC) as a Maintenance Therapy in Moderate to Severe Active Ulcerative Colitis

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  • The BLA application is based on P-III VISIBLE 1 study results assessing vedolizumab (SC-108mg) as maintenance therapy vs PBO in 216 patients with moderate to severely active UC achieving clinical response at 6wks. following vedolizumab (IV) at 0 & 2kws.
  • The P-III VISIBLE 1 study resulted in achieving clinical remission @52wks.with vedolizumab SC 108 mg (46.2% vs 14.3%). Additionally- clinical remission with vedolizumab IV 300 mg was observed similar to vedolizumab SC (42.6%)
  • Entyvio (vedolizumab- q2w) is a gut-selective biologic- targeting alpha4beta7 integrin- thus inhibiting its binding with MAdCAM-1 and its IV formulation has received approval in 60+ countries including the US & EU for active UC & Crohn’s disease

Ref: Takeda | Image:Takeda

Click here to­ read the full press release 

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