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
Ref: Takeda | Image:Takeda
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com