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Fedratinib

Inrebic

Extended indication Myelofibrosis
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Fedratinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other hematology
Extended indication Myelofibrosis
Proprietary name Inrebic
Manufacturer celgene
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Centre of expertise ErasmusMC, Radboud
Additional remarks JAK2 inhibitor

Registration

Registration route Centralised (EMA)
Submission date May 2019
Expected Registration May 2020
Orphan drug Yes
Registration phase Clinical trials
Additional remarks In 2013 zijn de klinische studies door Sanofi stopgezet wegens ernstige bijwerkingen (Wernicke’s encephalopathie). Celgene heeft Federatinib nu opgekocht.

Therapeutic value

Current treatment options Verschillende
Therapeutic value No judgement
Substantiation Milt verkleining, symptom score reduction
Frequency of administration 1 times a day
Dosage per administration 400 mg
References NCT01437787; NCT01523171

Expected patient volume per year

Patient volume

20 - 143

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 143 diagnoses in 2016. De inschatting van experts 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 Polycythemia Vera
References Fabrikant

Other information

There is currently no futher information available.