Vedolizumab Medicine 04 June 2026 Extended indication Ulcerative colitis (UC) and of Crohn’s disease (CD) in the paediatric population from 2 to less than 18 years for Entyvio 300 mg powder for concentrate for solution for infusion. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Vedolizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Ulcerative colitis (UC) and of Crohn’s disease (CD) in the paediatric population from 2 to less than 18 years for Entyvio 300 mg powder for concentrate for solution for infusion. Current proprietary name Already available biosimilars / generics Proprietary name Entyvio Manufacturer Takeda Portfolio holder Takeda Mechanism of action Immunosuppression Route of administration Intravenous Therapeutical formulation Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date April 2026 Expected Registration March 2027 Orphan drug Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References MLN0002-2005; MLN002-3024 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks