Bezlotoxumab Medicine 06 June 2023 Extended indication Extension of indication to include treatment for the prevention of recurrence of Clostridium difficile infection (CDI) in of the paediatric population (1 to 18 years of age) at high risk for recurrence of CDI. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bezlotoxumab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Extension of indication to include treatment for the prevention of recurrence of Clostridium difficile infection (CDI) in of the paediatric population (1 to 18 years of age) at high risk for recurrence of CDI. Current proprietary name Already available biosimilars / generics Proprietary name Zinplava Manufacturer MSD Portfolio holder MSD Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Recombinant gehumaniseerd monoklonaal antitoxine-antilichaam, geproduceerd in een ovariumcellijn van de Chinese hamster (CHO-cellen). Bindt met een hoge affiniteit aan Clostridioides difficile-toxine B waardoor het de activiteit ervan neutraliseert. Dit voorkomt bij een deel van de behandelde patiënten de terugkeer van een Clostridioides difficile-infectie (CDI) doordat het passieve immuniteit biedt tegen het toxine, geproduceerd door persisterende of nieuw verworven C. difficile-sporen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2023 Expected Registration January 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT01513239 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 drugs.com Additional remarks De kosten voor Zinplava intraveneus (25 mg/mL) bedragen in de VS $4.011 voor een hoeveelheid van 40 milliliter. De prijs in Nederland is nog niet bekend. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks