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

Clinical trials

Product

Active substance

Dapagliflozine

Domain

Infectious diseases

Reason of inclusion

Indication extension

Main indication

Other viral infections

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

Submission date

2021

Expected Registration

November 2021

Orphan drug

No

Registration phase

Clinical trials

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.