Extended indication Extension of indication to include patients from 4 months corrected gestational aged 1 year and abov
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Teduglutide
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Bowel diseases
Extended indication Extension of indication to include patients from 4 months corrected gestational aged 1 year and above With Short Bowel Syndrome
Proprietary name Revestive
Manufacturer Takeda
Mechanism of action Glucagon analogue
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date August 2021
Expected Registration February 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op termijn is er mogelijk een plaats voor teduglutide bij een bepaalde groep patiënten met short bowel syndroom. Op dit moment is er geen uitspraak te doen over de therapeutische waarde.
Frequency of administration 1 times a day
Dosage per administration 0.05 mg per kg body weight
References NCT03571516

Expected patient volume per year

References Expert opinie;
Additional comments Er wordt voorlopig geen groot patiëntvolume verwacht voor deze indicatie.

Expected cost per patient per year

Additional comments Prijs in Nederland is nog niet bekend. In Canada kost een flesje $904.00 dit is omgerekend €657,76.

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.