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Pitavastatine

Extended indication Reduce the risk of cardiovascular disease in HIV-infected adults
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Pitavastatine
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Extended indication Reduce the risk of cardiovascular disease in HIV-infected adults
Manufacturer Kowa
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Werkingsmechanimse: HMG-CoA reductase inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks NCT02344290

Therapeutic value

Therapeutic value No estimate possible yet
Additional remarks De werkgroep schat in dat pitavastatine waarschijnlijk niet geadviseerd gaat worden.

Expected patient volume per year

Patient volume

3,000 - 12,000

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks In verschillende landen staat het inzetten van een statine al in de richtlijnen. De verwachting is dat een andere effectieve statine ingezet gaat worden.

Expected cost per patient per year

References Drugs.com
Additional remarks De kosten in de Verenigde Staten voor pitavastatine orale tablet 1mg bedragen ongeveer $889 voor 90 tabletten. De prijs in de Verenigde Staten ligt doorgaans hoger dan in Nederland.

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.