Pravastatine / ​fenofibraat

Extended indication	Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40mg monotherapy or on another moderate-intensity statin regimen
Therapeutic value	Possibly no place in the treatment regimen
Registration phase	Registered

Product

Active substance	Pravastatine / fenofibraat
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Lipid-lowering medications
Extended indication	Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40mg monotherapy or on another moderate-intensity statin regimen
Proprietary name	Pravafenix
Manufacturer	Sage
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Extramural (GVS)
Additional remarks	Galephar Netherlands

Registration route	Centralised (EMA)
ATMP	No
Submission date	December 2023
Expected Registration	November 2024
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP-opinie september 2024.

Therapeutic value	Possibly no place in the treatment regimen
Substantiation	Er wordt geen therapeutische meerwaarde verwacht in Nederland voor een combinatiepreparaat met fenofibraat. Fibraten hebben alleen een indicatie ter preventie van pancreatitis bij ernstige hypertriglyceridemie of gecombineerde hyperlipidemie. Fenofibraat kan indien nodig ook los met andere statines worden gecombineerd. Echter worden fibraten niet veel voorgeschreven in Nederland (2).
References	NCT03214211 (1); Expertopinie (2).

References	Familiaire gecombineerde hyperlipidemie. Erfocentrum. 2023 (1); GIPdatabank. 2024 (2); Expertopinie (3).
Additional remarks	Familiaire gecombineerde hyperlipidemie komt voor bij ongeveer 1 op 300 Nederlanders (1). In 2023 waren er 95.672 gebruikers van pravastatin (2). Er wordt echter geen meerwaarde verwacht van dit combinatiepreparaat dus er worden weinig gebruikers verwacht (3).

There is currently nothing known about the expected cost.

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.