Ibrexafungerp Medicine 12 June 2019 Extended indication Invasive Candidiasis Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Ibrexafungerp Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Infectious diseases other Extended indication Invasive Candidiasis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Scynexis Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options echinocandinen Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Scynexis: SCY-078 has shown activity against Aspergillus and Candida, including against multidrug-resistant (MDR) species Candida auris as well as Pneumocystis. Orale toediening kan mogelijk ook voordelen opleveren t.o.v. bestaande behandelmethoden. Duration of treatment Frequency of administration Dosage per administration References Scynexis en de klinische studies: CARES, FURI. 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 Huidige behandelopties kosten rond de €400,00 per 100 mg poeder voor oplossing. 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 No Indication extensions References clinicaltrials.gov Additional remarks Op dit moment niet voor andere indicaties in fase III van het klinisch onderzoek. Other information Additional remarks