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Istradefylline

Extended indication Adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Istradefylline
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Parkinson's
Extended indication Adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes
Manufacturer Kyowa
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Adenosine A2 receptor antagonists

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional remarks FDA heeft dit geneesmiddel al geregistreerd voor bovenstaande indicatie.

Therapeutic value

Current treatment options levodopa/​carbidopa (en levodopa in combinatie met andere decarboxylaseremmers)
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 20 mg - 40 mg
References NCT01968031

Expected patient volume per year

References GIP databank
Additional remarks Het aantal gebruikers van ATC groep N04BC : Dopamineagonisten betreft ongeveer 50.000 patiënten. Een deel hiervan zal in aanmerking komen voor deze nieuwe formulering.

Expected cost per patient per year

Cost 800.00 - 1,000.00
References GIP databank
Additional remarks Kosten naar verwachting vergelijkbaar met levodopa in combinatie met andere decarboxylaseremmers

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.