Pemivibart Medicine 03 June 2025 Extended indication Pemivibart monotherapy for the prophylactic treatment of COVID-19 in moderately to severely immunocompromised adolescents, adults and the elderly who have had no recent exposure and are not currently infected with SARS-CoV-2. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pemivibart Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Pemivibart monotherapy for the prophylactic treatment of COVID-19 in moderately to severely immunocompromised adolescents, adults and the elderly who have had no recent exposure and are not currently infected with SARS-CoV-2. Current proprietary name Already available biosimilars / generics Proprietary name Pemgarda Manufacturer Invivyd Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Solution For Parenteral Intravenous Infusion Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration August 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog weinig te zeggen over plaatsbepaling. Monoklonaal antistof tegen SARS-CoV-2. Monoklonale neutraliserende antistoffen werken goed tegen SARS-CoV-2 als therapie en als profylaxe. Grootste probleem blijft de resistentie. Bij eerdere monoklonale antistoffen tegen SARS-CoV-2 sprake van resistentie door evolutie van het virus of door escape aan onze eigen immuunrespons. . Duration of treatment Frequency of administration 1 times every 3 months Dosage per administration 4.500 mg References NCT06039449 (CANOPY) Additional remarks Pemgarda wordt een maal per drie maanden toegediend, vier keer per jaar. 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 € < 23,800.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Drugs.com (1). Additional remarks Een dosis Pemgarda (4.500mg) kost $6.789 in de Verenigde Staten (1). Dit is omgerekend €5.942. Vier toedieningen per jaar zijn dan €23.768. 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