Semzuvolimab Medicine 07 December 2022 Extended indication Monotherapy in HIV-1 Infected Adults Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Semzuvolimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication HIV Extended indication Monotherapy in HIV-1 Infected Adults Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer United Biomedical Portfolio holder Mechanism of action Virus inhibitor 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 Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum fase 3 studie in december 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 25 mg/kg References NCT04406727 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 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