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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post