Extended indication Treatment of orthopoxvirus disease
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Tecovirimat
Domain Infectious diseases
Reason of inclusion New medicine (specialit├ę)
Main indication Viral infections
Extended indication Treatment of orthopoxvirus disease
Proprietary name Tpoxx
Manufacturer SIGA Technologies
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional comments Orthopoxvirus p37 protein inhibitor.

Registration

Registration route Centralised (EMA)
Submission date October 2020
Expected Registration December 2021
Registration phase Registration application pending
Additional comments Tecovirimat is sinds 2018 geregistreerd door de FDA voor behandeling van pokken, waarbij een behandelduur van 14 dagen wordt aangehouden. Dit orale middel blokkeert het virale envelopeiwit P37, zodat er geen nieuwe infectieuze virussen vanuit geïnfecteerde cellen kunnen ontsnappen. Het is geregistreerd voor volwassenen en kinderen vanaf 13 kg.

Therapeutic value

Therapeutic value No judgement
Dosage per administration 600 mg
References NCT02474589

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.