Expand all sections

Pinda extract

Viaskin Peanut

Extended indication Pinda-allergie in kinderen van 4-11 jaar
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Pinda extract
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Allergy
Extended indication Pinda-allergie in kinderen van 4-11 jaar
Proprietary name Viaskin Peanut
Manufacturer DBV Technologies
Route of administration Transdermal
Therapeutical formulation Band Aid
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks FDA fast track designation

Therapeutic value

Therapeutic value No judgement
Substantiation Studie loopt nog, te vroeg om uitspraken te doen over de effectiviteit. Lijkt weinig bijwerkingen met zich mee te brengen.
Duration of treatment Average 12 month / months
Frequency of administration 1 times a day
Dosage per administration 250 µg
References NCT02636699

Expected patient volume per year

Patient volume

7,500 - 15,000

Market share is generally not included unless otherwise stated.
References Stichting voedselallergie; CBS
Additional remarks Volgens de Stichting Voedselallergie komt pinda-allergie voor bij 0,5-1% van de kinderen in westerse landen. Het totaal aantal kinderen van de leeftijden 4-11 in Nederland in 2017 bedroeg ongeveer 1,5 miljoen. 0,5-1% hiervan bedraagt 7.500-15.000. De precieze indicatiestelling zal moeten uitwijzen welke kinderen hier voor in aanmerking komen.

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 Alle leeftijden
References Clinicaltrials.gov

Other information

There is currently no futher information available.