APN01 Medicine 08 December 2020 Extended indication Patients with COVID-19 Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance APN01 Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Patients with COVID-19 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Apeiron Biologics Portfolio holder Mechanism of action Virus inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks APN01 (rhACE2) is een recombinante versie van de receptor ACE2, die essentieel is voor het binnendringen van cellen door SARS-CoV2. APN01 kan zo mogelijk virusdeeltjes wegvangen en daarmee infectie remmen. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum fase 3 studie in september 2020. Studies met betrekking tot Covid-19 zullen later geregistreerd worden dan verwacht, aangezien de inclusie van patiënten meer tijd neemt dan van te voren ingeschat is. Therapeutic value Current treatment options Remdesivir Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT04335136 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel 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 Yes Indication extensions Acute lung injury; Adult respiratory distress syndrome; Pulmonary arterial hypertension References fase 3 studies Adis Insight Additional remarks Other information Additional remarks