Udenafil Medicine 10 June 2020 Extended indication Single Ventricle Heart Disease Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Udenafil Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Single Ventricle Heart Disease Current proprietary name Already available biosimilars / generics Proprietary name Zydena Manufacturer Mezzion Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Type 5 cyclic nucleotide phosphodiesterase inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Datum indiening en verwachte registratie gebaseerd op primary completion date fase 3 studie in juli 2020. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03013751 Additional remarks Expected patient volume per year Patient volume > 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Plantinga et al. Ned Tijdschr Geneeskd. 2001;145:85-90 Additional remarks Het hypoplastisch linkerhartsyndroom (HLHS) komt voor bij 1-2 per 10.000 levendgeborenen per jaar. In 2001 bedroeg deze groep in Nederland ruim 100 patiënten. 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