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Lenzumestrocel

Neuronata-R

Extended indication Lenzumestrocel in combination with riluzole for treatment of familial or sporadic amyotrophic latera
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Lenzumestrocel
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication ALS
Extended indication Lenzumestrocel in combination with riluzole for treatment of familial or sporadic amyotrophic lateral sclerosis in adults over 25 years of age and elderly
Proprietary name Neuronata-R
Manufacturer CorestemChemon
Route of administration Intrathecal
Budgetting framework Intermural (MSZ)
Additional remarks Neuronata-R® (lenzumestrocel) is een autoloog beenmerg-afgeleid mesenchymale stamcel (BM-MSC) product.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date March 2025
Expected Registration April 2026
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Riluzol verlengt de overleving van mensen met ALS, maar geneest het niet.
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen fase 3-resultaten bekend.
References NCT01363401 (1); NCT04745299 (ALSummit) (2)

Expected patient volume per year

References Stichting ALS Nederland. 2024 (1).
Additional remarks In Nederland leven zo'n 1.500 mensen met amyotrofische laterale sclerose (ALS) (1).

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.