Extended indication Primary systemic amyloidosis (AL amyloïdose).
Therapeutic value No judgement
Registration phase Withdrawn

Product

Active substance Neod001
Domain Metabolism and Endocrinology
Main indication Metabolic diseases
Extended indication Primary systemic amyloidosis (AL amyloïdose).
Manufacturer prothena
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Monoklonaal antilichaam gericht tegen amyloïden

Registration

Registration route Centralised (EMA)
Particularity New medicine
Expected Registration 2020
Orphan drug Yes
Registration phase Withdrawn
Additional remarks Ontwikkeling is gestopt per april 2018. Primaire eindpunten zijn niet gehaald.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

87 - 218

Market share is generally not included unless otherwise stated.

References Amyloidose Nederland
Additional remarks De geschatte incidentie ligt tussen de 5,1 en 12,8 per miljoen inwoners per jaar, dit betekent voor Nederland dus 87-218 patiënten per jaar.

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.