Version 3

Imipenem / cilastatin / relebactam

Medicine

Extended indication Recarbrio is indicated in adult and paediatric patients from birth for: - Treatment of hospital-acquired pneumonia (HAP), including ventilator associ
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registered

Product

Active substance Imipenem / cilastatin / relebactam
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Recarbrio is indicated in adult and paediatric patients from birth for: - Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) (see sections 4.4 and 5.1). - Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP. - Treatment of infections due to aerobic Gram-negative organisms with limited treatment options (see sections 4.2, 4.4, and 5.1).
Proprietary name Recarbrio
Manufacturer MSD
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Indicatieuitbreiding naar pediatrische patiënten vanaf geboorte.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2025
Expected Registration January 2026
Orphan drug Yes
Registration phase Registered
Medicine sluice Rejected
Additional remarks Positieve CHMP-opinie in december 2025, EC registratie in januari 2026.

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.
Substantiation Een meta-analyse van RCTs laat zien dat MI/CS/REL non-inferieur is aan standaard behandelopties bij carbapenemgevoelige of carbapenemresistente pathogenen. De verwachting is dat dit niet veel ingezet zal worden.
References NCT03969901; Lei et al. BMC Infect Dis. 2025; Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks De inzet van Recarbio is beperkt in Nederland. Deze indicatieuitbreiding naar niet-volwassenen zal daarom een zeer gering effect hebben op het patiëntvolume.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information