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Eltrombopag

Revolade

Extended indication Extension of indication to include second-line treatment of paediatric patients aged 2 years and abo
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Eltrombopag
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to include second-line treatment of paediatric patients aged 2 years and above with acquired severe aplastic anaemia (SAA)
Proprietary name Revolade
Manufacturer Novartis
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Thrombopoietin receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2024
Expected Registration July 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van EMA-indiening in september 2024 en een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03025698 (CETB115E2201)

Expected patient volume per year

References Horizonscan Geneesmiddelen eltrombopag (1)
Additional remarks De incidentie bedraagt ongeveer 2:1.000.000, dit zijn ongeveer 36 Nederlandse patiënten per jaar (1). Het patiëntvolume dat in aanmerking komt voor deze pediatrische indicatieuitbreiding zal gering zijn.

Expected cost per patient per year

Cost < 39,500.00
References Horizonscan Geneesmiddelen eltrombopag (1)

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.