Extended indication Graves' Orbitopathy (Thyroid Eye Disease)
Therapeutic value Possible added value
Registration phase Clinical trials

Product

Active substance Teprotumumab
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Other chronic immune diseases
Extended indication Graves' Orbitopathy (Thyroid Eye Disease)
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Human IgG1k monoclonaal antilichaam gericht tegen insulin-like growth factor-1 receptor (IGF-1R) .

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion date fase III OPTIC study in juni 2019

Therapeutic value

Current treatment options Thyreostatica, riodioactief jodium, chirurgie.
Therapeutic value Possible added value
Substantiation Resulaten van een fase 2 klinische studie zijn erg veelbelovend.
Frequency of administration 1 times every 3 weeks
Dosage per administration 10-20 mg/kg
References NCT03298867; Smith et al. N Engl J Med 2017; 376:1748-1761

Expected patient volume per year

Patient volume

< 3,750

Market share is generally not included unless otherwise stated.

References Schildklier.nl
Additional remarks Ongeveer 75.000 mensen hebben de ziekte van Graves, 20% daarvan heeft de oogaandoening Graves ophthalmopathie. Ongeveer 5% loopt het risico de oogziekte in ernstige vorm te ontwikkelen (3.750). Gezien de inclusiecriteria van de klinische studie zal het vooral gaan om deze laatste groep patiënten.

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

Indication extension No

Other information

There is currently no futher information available.