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ABBV-8E12

Extended indication Progressive Supranuclear Palsy (PSP)
Therapeutic value No judgement
Registration phase Withdrawn

Product

Active substance ABBV-8E12
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Neurological disorders other
Extended indication Progressive Supranuclear Palsy (PSP)
Manufacturer Abbvie
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Gehumaniseerd recombinant antilichaam gericht tegen tau.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug Yes
Registration phase Withdrawn
Additional remarks Programma door AbbVie gestaakt, product komt niet op de markt.

Therapeutic value

Current treatment options Geen, alleen symptoombestrijding.
Therapeutic value No judgement
References NCT02985879

Expected patient volume per year

Patient volume

< 1,000

Market share is generally not included unless otherwise stated.
References Erfelijkheid.nl; Donker Kaat et al. Ned Tijdschr Geneeskd. 2004;148:519-23
Additional remarks Naar schatting krijgen 5-6 op de 100.000 mensen PSP. In Nederland zou dit dan gaan om ongeveer 1.000 mensen.

Expected cost per patient per year

Additional remarks Aangezien er geen huidige behandeling voor PSP voorhanden is zal er naar verwachting een hoge prijs gevraagd worden bij een bewezen therapeutische waarde.

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 Alzheimer's disease (fase 2)
References Clinicaltrials.gov

Other information

There is currently no futher information available.