Edaravone / dexborneol Medicine 03 December 2024 Extended indication Acute ischaemic stroke Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Edaravone / dexborneol Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Antithrombotic medications Extended indication Acute ischaemic stroke Current proprietary name Already available biosimilars / generics Proprietary name Sanbexin Manufacturer Simcere Portfolio holder Mechanism of action Antioxidant Route of administration Sublingual Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Type of trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Ingediend bij NMPA (medicijnautoriteit van China) in juni 2023. Het is nog onbekend wanneer dit middel precies wordt ingediend bij EMA. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog niet genoeg studieresultaten bekend om een inschatting te maken. Duration of treatment Frequency of administration 2 times a day Dosage per administration edaravone/dexborneol: 30mg/6mg References NCT04950920 (TASTE-SL) (1); Wang et al. Stroke Vasc Neurol. 2024 (2). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Cijfers hart- en vaatziekten. Hartstichting. 2024 (1). Additional remarks In 2022 werden ruim 38.000 mensen getroffen door een beroerte (1). Het is nog onduidelijk bij welke patiëntgroep dit middel precies ingezet gaat worden. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks