Extended indication Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mep
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Mepolizumab
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Other lung
Extended indication Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab).
Proprietary name Nucala
Manufacturer GSK
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Monoklonaal antilichaam gericht tegen IL5; toedieningsvorm is poeder voor oplossing voor injectie (flacon) en oplossing voor injectie (voorgevulde pen)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2020
Expected Registration September 2021
Registration phase Registration application pending

Therapeutic value

Current treatment options Meestal wordt bij behandeling van CRSwNP volstaan met INC. Een gedeelte wordt geopereerd en als dat niet helpt kunnen biologicals worden ingezet. Dupilumab is sinds kort beschikbaar.
Therapeutic value No judgement
Frequency of administration 1 times every 4 weeks
Dosage per administration 100 mg
References NCT04607005

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.