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AR101

Extended indication Pinda-allergie
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance AR101
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Allergy
Extended indication Pinda-allergie
Manufacturer Aimmune
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date March 2019
Expected Registration April 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks PALISADE studie: met primary efficacy endpoint; efficacy across ages. Aimmune heeft de intentie om een registratieaanvraag in te dienen bij de EMA in de eerste helft van 2019.

Therapeutic value

Therapeutic value No judgement
Substantiation Effectief middel, maar wel met bijwerkingen.
References NCT02635776

Expected patient volume per year

Patient volume

< 170,000

Market share is generally not included unless otherwise stated.
References Stichting Voedselallergie
Additional remarks In Nederland wordt geschat dat meer dan 1% een pinda-allergie heeft. Dit zou dus neerkomen op 170.000 mensen. Welk deel van deze mensen in aanmerking komt voor gebruik van AR101 hangt af van de studieresultaten en de uiteindelijke indicatiestelling.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.