Shots:

• The CHMP’s positive opinion is based on P-III VISIBLE study assessing vedolizumab (SC) as maintenance therapy vs PBO in ~1000 patients with moderately to severely active UC & CD who achieved clinical response @6wks. following the 2doses of vedolizumab (IV) @0 & 2wks.
• EC will now review the CHMP’s positive opinion and if approved- vedolizumab will be the only maintenance therapy for UC & CD with both IV & SC formulation in the EU
• Vedolizumab SC is a gut-selective biologic act by inhibiting alpha4beta7 integrin binding to MAdCAM-1 and not VCAM-1 and is expected to be available in both pre-filled syringe and a pre-filled pen

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 Ref: Takeda | Image: Takeda