Ersodetug Medicine 04 December 2025 Extended indication Ersodetug in combination with standard of care therapy for treatment of Congenital hyperinsulinaemic hypoglycaemia in infants, toddlers, children, adolescents and adults from 3 months to 45 years of age. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ersodetug Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Ersodetug in combination with standard of care therapy for treatment of Congenital hyperinsulinaemic hypoglycaemia in infants, toddlers, children, adolescents and adults from 3 months to 45 years of age. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer CUTISS Portfolio holder CUTISS Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine with Priority Medicines (PRIME) ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Diazoxide 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 NCT04538989 Additional remarks De vraag is of het buiten het ziekenhuis gebruikt gaat worden. Wellicht soms in een andere instelling zoals verpleeghuis. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Orphanet (1); NTVG(2); Additional remarks De wereldwijde gemiddelde prevalentie bij de geboorte bedraagt 1 op 27.000, maar kan tot 1 op 2.500 bedragen in gemeenschappen met substantiële bloedverwantschap. In Aalten en Silvolde werd een hoge prevalentie waargenomen (1 op 6.930 inwoners), waarschijnlijk door een gemeenschappelijke voorouder (2). 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