Sevasemten Medicine 04 June 2026 Extended indication Sevasemten monotherapy for treatment of Beckerʼs muscular dystrophy in adults up to 50 years of age with a history of being ambulatory beyond 16 years of age without steroids, and beyond 18 years of age with steroids. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Sevasemten Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases other Extended indication Sevasemten monotherapy for treatment of Beckerʼs muscular dystrophy in adults up to 50 years of age with a history of being ambulatory beyond 16 years of age without steroids, and beyond 18 years of age with steroids. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Servier Portfolio holder Servier Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: myosine inhibitor. Edgewise Therapeutics heeft het middel in juni 2026 verkocht aan Servier. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date February 2027 Expected Registration March 2028 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05291091 (GRAND CANYON) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks