Extended indication Polycythemia vera
Therapeutic value No judgement
Registration phase Withdrawn

Product

Active substance Fedratinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other hematology
Extended indication Polycythemia vera
Proprietary name Inrebic
Manufacturer celgene
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks JAK2 inhibitor

Registration

Registration route Centralised (EMA)
Registration phase Withdrawn
Additional remarks In 2013 zijn de klinische studies door Sanofi stopgezet wegens ernstige bijwerkingen (Wernicke’s encephalopathie). Celgene heeft Federatinib nu opgekocht. Ontwikkeling wordt niet doorgezet.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 400 mg

Expected patient volume per year

Patient volume

20

Market share is generally not included unless otherwise stated.

Additional remarks De inschatting is 20 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 Yes
Indication extensions Myelofibrosis
References Fabrikant

Other information

There is currently no futher information available.