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Tecovirimat

Tpoxx

Extended indication Treatment of orthopoxvirus disease
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tecovirimat
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
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 remarks Orthopoxvirus p37 protein inhibitor.

Registration

Registration route Centralised (EMA)
Submission date October 2020
Expected Registration December 2021
Registration phase Registration application pending
Additional remarks 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 13kg.

Therapeutic value

Therapeutic value No estimate possible yet
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

References https://www.keionline.org/21725
Additional remarks In de Verenigde Staten wordt een prijs van $255 per dosis gevraagd.

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.