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Semzuvolimab

Extended indication Monotherapy in HIV-1 Infected Adults
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Semzuvolimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication HIV
Extended indication Monotherapy in HIV-1 Infected Adults
Manufacturer United Biomedical
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Inmiddels ingediend bij de FDA.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase 3 resultaten moeten nog worden afgewacht.
Frequency of administration 1 times every 2 weeks
Dosage per administration 25 mg/kg
References NCT04406727

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.
References Monitoring Report 2017 (HIV Monitoring, pagina 41), SHM (1). Expertopinie (2)
Additional remarks In 2016 waren in Nederland 19.035 mensen met HIV in zorg. 97% hiervan (18.552) was ooit gestart met de antiretrovirale combinatietherapie (cART). In 2019 waren er 580 nieuwe diagnoses van HIV. De werkgroep schat in dat er maximaal 10 patiënten in aanmerking zullen komen in het geval van positieve fase 3 resultaten.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.