Reldesemtiv Medicine 04 June 2024 Extended indication Amyotrophic lateral sclerosis (ALS) Therapeutic value No estimate possible yet Total cost 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) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Astellas Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Transdermal system Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Astellas Werkingsmechanisme: Troponin stimulants Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date Expected Registration Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration References Additional remarks NCT04944784 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References als.nl Additional remarks In Nederland leven gemiddeld 1.500 mensen met ALS. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks