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Reldesemtiv

Extended indication Amyotrophic lateral sclerosis (ALS)
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Reldesemtiv
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication ALS
Extended indication Amyotrophic lateral sclerosis (ALS)
Manufacturer Astellas
Route of administration Oral
Therapeutical formulation Transdermal system
Budgetting framework Extramural (GVS)
Additional remarks Fabrikant: Astellas Werkingsmechanisme: Troponin stimulants

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Orphan drug Yes
Registration phase No registration expected

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase 3 (COURAGE) studie is in 2023 vroegtijdig beëindigd door de fabrikant (Cytokinetics) wegens het ontbreken van een effect bij de tussentijdse analyse.
Additional remarks NCT04944784

Expected patient volume per year

References als.nl
Additional remarks In Nederland leven gemiddeld 1.500 mensen met ALS.

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.