Amlitelimab Medicine 04 June 2026 Extended indication Atopic dermatitis Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Amlitelimab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Atopic dermatitis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Sanofi Portfolio holder Sanofi Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Human anti-OX40 ligand monoclonal antibody. Bekostiging mogelijk intramuraal, conform dupilumab. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Biologicals en JAK-remmers 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 NCT06181435 (COAST 2); NCT06224348 (SHORE); NCT06241118 (AQUA) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Volksgezondheid.info (1) Additional remarks In 2022 kregen naar schatting 154.100 mensen de diagnose constitutioneel eczeem bij de huisarts (1). Het aantal patiënten dat voor dit middel in aanmerking komt hangt nog van onder andere de effectiviteit, de prijs en de plaatsbepaling. Expected cost per patient per year Cost References Additional remarks De prijs is nog niet bekend. Op basis van de mediane kosten van producten in dezelfde ATC-groep wordt een prijs van 18.000 per patiënt per jaar ingeschat. 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