Version 1

Regdanvimab

Medicine

Extended indication In Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19.
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Regdanvimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication In Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19.
Manufacturer Celltrion
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks CT-P59 werkt als een neutraliserende antilichaamcocktail.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity Unknown
ATMP Unknown
Submission date February 2021
Expected Registration July 2021
Orphan drug No
Registration phase Positive CHMP opinion

Therapeutic value

Current treatment options Remdesivir
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Preklinische gegevens voor de kandidaat behandeling vertoonden een 100-voudige verlaging van de virale belasting van SARS-CoV-2, alsmede een beperking van de ontsteking van de longen. In de fase 2-3 studie CT-P59 werd een statistisch verschil in het ontwikkelen van klachten die leiden tot ziekenhuis opname gevonden: in alle patiënten 4,4% versus 8,7% en in hoog risico patiënten 5,5% versus 12,7% (100 patiënten placebo/ 200 regdanvimab).
References NCT04602000; https://www.ema.europa.eu/en/documents/referral/celltrion-use-regdanvimab-treatment-covid-19-article-53-procedure-conditions-use-conditions_en.pdf

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
Additional remarks Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel

Expected cost per patient per year

Cost € 1,000.00 - 2,000.00

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.
Additional remarks Volgens Franse media zal er een prijs van tussen de €1.000 en €2.000 gevraagd gaan worden.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information