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Bamlanivimab/ etesevimab

Extended indication Combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Bamlanivimab/ etesevimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
Manufacturer Eli Lilly
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Bamlanivimab and etesevimab are two monoclonal antibodies with activity against COVID-19

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date March 2021
Expected Registration November 2021
Orphan drug No
Registration phase Registration application pending
Additional remarks Hoewel Lilly in een eerder stadium met VWS sprak over de levering van bamlanivimab. Alleen heeft Lilly inmiddels besloten om de monotherapie niet meer verder te vervolgen en zich te focussen op de combinatie therapie bamlanivimab en etesivimab.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation In de fase 3 studie werden1.035 hoog risico patiënten met vroege covid binnen 3 dagen behandeld. Er werd 70% reductie in Covid gerelateerde ziekenhuisopname waargenomen (11/518 versus 36/517). En geen overlijdens in actieve arm versus 10 in de placebo groep.
References BLAZE-1; BLAZE-2

Expected patient volume per year

Additional remarks Het mogelijke patiëntvolume per jaar zal afhankelijk zijn van het verloop van de epidemie.

Expected cost per patient per year

References https://www.clinicaltrialsarena.com/comment/eli-lillys-monoclonal-antibody-bamlanivimab/
Additional remarks Uit een artikel blijkt dat de Verenigde Staten voor $1.250 per 700mg bamlanivimab heeft ingekocht van de fabrikant. De prijs in Nederland is nog niet bekend.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.