Udenafil

Active substance
Udenafil
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other medication for cardiovascular diseases
Extended indication
Single Ventricle Heart Disease

1. Product

Proprietary name
Zydena
Manufacturer
Mezzion
Mechanism of action
Enzyme inhibitor
Route of administration
Oral
Budgetting framework
Extramural (GVS)
Additional comments
Type 5 cyclic nucleotide phosphodiesterase inhibitor.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
2021
Expected Registration
2022
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Datum indiening en verwachte registratie gebaseerd op primary completion date fase 3 studie in juli 2020.

3. Therapeutic value

Therapeutic value
No judgement
References
NCT03013751

4. Expected patient volume per year

Patient volume

> 100

Market share is generally not included unless otherwise stated.

References
Plantinga et al. Ned Tijdschr Geneeskd. 2001;145:85-90
Additional comments
Het hypoplastisch linkerhartsyndroom (HLHS) komt voor bij 1-2 per 10.000 levendgeborenen per jaar. In 2001 bedroeg deze groep in Nederland ruim 100 patiënten.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

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.