Fostemsavir

Active substance
Fostemsavir
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Viral infections
Extended indication
HIV/aids in heavily treatment experienced patients.

1. Product

Manufacturer
ViiV
Mechanism of action
HIV inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
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.

2. Registration

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

3. 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

4. Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

Additional comments
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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
SPS

9. Other information

There is currently no futher information available.