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.