Extended indication Extension of indication to include patients from 4 months corrected gestational aged 1 year and above
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
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 January 2022
Expected Registration November 2022
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 0.05 mg per kg body weight
References NCT03571516

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.