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Bevacizumab-vikg

Lytenava

Extended indication Wet age-related macular degeneration
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Bevacizumab-vikg
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Wet age-related macular degeneration
Proprietary name Lytenava
Manufacturer Outlook Therapeutics
Mechanism of action Angiogenesis inhibitor
Route of administration Intravitreal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
ATMP No
Submission date December 2022
Expected Registration February 2024
Orphan drug No
Registration phase Registration application pending
Additional remarks Dit product is als nieuw middel ingediend bij de EMA (gegeven de nieuwe toedieningsvorm). Negatieve CHMP opinie ontvangen in november 2021. Herindiening december 2022.

Therapeutic value

Current treatment options Ranibizumab, aflibercept, brolucizumab
Therapeutic value Possible equal value
Substantiation Dit betreft een geregistreerde versie van de doorgeleverde bereiding van bevacizumab ooginjecties.
Dosage per administration 1,25mg
References NORSE studies

Expected patient volume per year

Patient volume

> 50,000

Market share is generally not included unless otherwise stated.
References Opendisdata;
Additional remarks Dit betreft een intravitreale versie van de nu de doorgeleverde bereiding van bevacizumab ooginjecties. In 2019 zijn er bij ongeveer 50.000 patiënten met AMD bevacizumab injecties toegediend. Dit aantal neemt echter jaarlijks toe.

Expected cost per patient per year

References medicijnkosten.nl;
Additional remarks De kosten zijn mogelijk vergelijkbaar met ranibizumab. Lucentis, 0,23ml injectievloeistof 10mg/ml €726,50. De kosten zullen hoger uitvallen dan de doorgeleverde bereiding van bevacizumab ooginjecties.

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 Branch retinal vein occlusion; Diabetic macular oedema.
References Adis Insight

Other information

There is currently no futher information available.