Alirocumab

Extended indication	Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Alirocumab
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Lipid-lowering medications
Extended indication	Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies.
Proprietary name	Praluent
Manufacturer	Sanofi
Portfolio holder	Sanofi
Mechanism of action	Enzyme inhibitor
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)
Additional remarks	PCSK9 remmer

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	No estimate possible yet

There is currently nothing known about the expected patient volume.

Additional remarks	Voor alirocumab is een financieel arrangement van toepassing tot 1 januari 2027. Gemiddelde prijs per 1 wegwerpspuit Praluent, 1 ml injectievloeistof 150 mg/ml € 225,66 incl. btw.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.