Extended indication Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival.
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Dapagliflozine
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication COVID-19
Extended indication Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival.
Proprietary name Forxiga
Manufacturer AstraZeneca
Mechanism of action SGLT inhibitor
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug No
Registration phase No registration expected
Additional comments De trial heeft de primaire eindpunten niet gehaald.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De trial heeft de primaire eindpunten niet gehaald.
Duration of treatment Average 30 day / days
Frequency of administration 1 times a day
Dosage per administration 10mg
References NCT04350593 (DARE-19); https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-farxiga-covid-19-dare-19-phase-iii-trial.html

Expected patient volume per year

Additional comments Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel

Expected cost per patient per year

Cost 44.00
References G-standaard
Additional comments Uitgaande van 100% therapietrouw en tabletten van 10mg en de prijs in de G-Standaard (€1,47 per tablet)

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

Indication extension Yes
Indication extensions Renal failure
References adisinsght
Additional comments Lopende fase 3 studie

Other information

There is currently no futher information available.