Expand all sections

Remdesivir

Veklury

Extended indication Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Remdesivir
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication COVID-19
Extended indication Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
Proprietary name Veklury
Manufacturer Gilead
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks RNA-replicaseremmers.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration September 2022
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie september 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De winst die in klinische studies is aangetoond is minder dan verwacht en er zijn veel andere (betere) behandelopties beschikbaar.

Expected patient volume per year

Additional remarks In Nederland zal dit naar verwachting niet veel gebruikt gaan worden.

Expected cost per patient per year

Cost 1,840.00 - 5,515.00
References www.medicijnkosten.nl (Lijstprijs inclusief BTW) SmPC Veklury
Additional remarks Een kuur duurt tussen de 5 en 10 dagen. Op de eerste dag wordt een dubbele dosering toegediend. For patients at high risk of progressing to severe COVID-19, including hospitalisation and not requiring supplemental oxygen, the total duration of treatment should be 3 days.

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.