Zoliflodacin Medicine 03 December 2024 Extended indication Uncomplicated gonorrhoea Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Zoliflodacin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Uncomplicated gonorrhoea Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Innoviva Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Granules for oral suspension Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion (estimated): 30 augustus 2023. De verwachte goedkeuring door de FDA wordt door de fabrikant geschat in 2025 (https://gardp.org/rfp/gardp-request-for-proposal-for-managed-access-program-for-zoliflodacin/). Therapeutic value Current treatment options Ceftriaxon Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is een groot voordeel dat dit middel oraal toegediend kan worden ten opzichte van intramusculair ceftriaxon. Waarschijnlijk zal een van deze twee middelen gekozen worden binnen de SOA-klinieken. De keuze is sterk afhankelijk van de uiteindelijke prijs van dit middel (2). Duration of treatment Frequency of administration Dosage per administration References NCT03959527 (1); Expertopinie (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 Keyaert et al. RIVM. 2024 (1); Expertopinie (2). Additional remarks Het aantal diagnoses gonorroe in Nederland in 2023 was13.853 (1). Het daadwerkelijke patiëntvolume is nog niet met zekerheid in te schatten en is sterk afhankelijk van het beleid van de SOA-klinieken (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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks