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

Shots:

• 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

Click here to read full press release/ article | Ref: Takeda | Image:Ti Group