Extended indication Transthyretin-mediated amyloidosis (ATTR amyloidosis).
Therapeutic value No judgement
Registration phase Unknown

Product

Active substance Patisiran
Domain Neurological disorders
Main indication Neurological disorders other
Extended indication Transthyretin-mediated amyloidosis (ATTR amyloidosis).
Manufacturer Alnylam
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: siRNA gericht tegen transthyretine.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Expected Registration 2019
Orphan drug Yes
Registration phase Unknown

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume < 340

Market share is generally not included unless otherwise stated.

References EMA
Additional remarks At the time of designation, ATTR amyloidosis affected less than 0.2 in 10,000 people in the European Union (EU).' (EMA)

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information