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Nirsevimab

Beyfortus

Extended indication Extension of indication to include treatment of children up to 24 months of age who remain vulne
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Nirsevimab
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Viral infections other
Extended indication Extension of indication to include treatment of children up to 24 months of age who remain vulnerable to severe Respiratory Syncytial Virus (RSV) disease through their second RSV season
Proprietary name Beyfortus
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Immunostimulation
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2023
Expected Registration February 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.