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Fostemsavir

Extended indication HIV/aids in heavily treatment experienced patients.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Fostemsavir
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication HIV/aids in heavily treatment experienced patients.
Manufacturer ViiV
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Scrip pipeline watch 3 nov 2017: BRIGHTE trail, positive results in heavily pretreated patients. Antiretroviral designed to prevent HIV attachment to and entry into CD4+ T cells, first-in-class.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation Dit middel zal naar verwachting worden ingezet als een laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt.
Duration of treatment lifetime
Frequency of administration 2 times a day
Dosage per administration 600 mg
References clinicaltrials.gov, NCT02362503

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
Additional remarks De schatting is dat er maximaal 500 patiënten in aanmerking zullen komen voor dit middel. Dit gegeven dat het middel wordt ingezet als laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt.

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

Indication extension No
References SPS

Other information

There is currently no futher information available.