Angiotensin II

Active substance
Angiotensin II
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other medication for cardiovascular diseases
Extended indication
Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.

1. Product

Proprietary name
Giapreza
Manufacturer
La Jolla
Mechanism of action
Receptor agonist
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Angiotensin-type-1-receptor-agonists

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
July 2018
Expected Registration
August 2019
Orphan drug
No
Registration phase
Registered
Additional comments
Positieve CHMP-opinie in juni 2019. Geregistreerd per 23/08/2019.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
De inschatting is dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland.
Duration of treatment
Not found
Dosage per administration
starten met 20 ng/ kg/min voor 3 uur

4. Expected patient volume per year

References
SPS
Additional comments
In de Verenigde Staten zijn 300.000 personen die in aanmerking zouden komen voor het geneesmiddel, teruggerekend naar Nederland zou dat gaan 15.000 patiënten. Echter, gezien de verwachting van de werkgroep dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland zal het aantal patiënten beperkt blijven.

5. Expected cost per patient per year

Cost
1,400
References
https://www.drugs.com/price-guide/giapreza; EPAR
Additional comments
Een flacon Giapreza 2,5 mg/ml kost in de Verenigde Staten $1.576 (~€1.400). Een flacon is voldoende voor 1 dosis.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.