Extended indication Extension of indication to include treatment for the prevention of recurrence of Clostridium diffici
Therapeutic value No estimate possible yet
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.
Proprietary name Zinplava
Manufacturer MSD
Portfolio holder MSD
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)
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
ATMP No
Submission date March 2023
Expected Registration January 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT01513239

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.