Crisaborole

Extended indication	Treatment of orthopoxvirus disease
Therapeutic value	No estimate possible yet
Registration phase	Positive CHMP opinion

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	Tecovirimat SIGA
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 route	Centralised (EMA)
Submission date	October 2020
Expected Registration	January 2022
Orphan drug	Yes
Registration phase	Positive CHMP opinion
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. Positieve CHMP opinie ontvangen in november 2021 voor marketing authorisation under exceptional circumstances.

Therapeutic value	No estimate possible yet
Substantiation	De verwachting is dat dit niet gebruikt zal worden in Nederland.
Dosage per administration	600 mg
References	NCT02474589

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.