Extended indication Patients with COVID-19
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance APN01
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections
Extended indication Patients with COVID-19
Manufacturer Apeiron Biologics
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments 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
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments 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
Frequency of administration 2 times a day
References NCT04335136

Expected patient volume per year

References Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Acute lung injury; Adult respiratory distress syndrome; Pulmonary arterial hypertension
References fase 3 studies Adis Insight

Other information

There is currently no futher information available.