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Lerodalcibep

LIB003

Extended indication Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Lerodalcibep
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Lipid-lowering medications
Extended indication Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy with history of CVD, monotherapy for add-on treatment
Proprietary name LIB003
Manufacturer LIB Therapeutics
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks PCSK9-remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion (actual): 15 november 2023.

Therapeutic value

Current treatment options PCSK9-remmers (alirocumab, evolocumab), inclisiran
Therapeutic value No estimate possible yet
Substantiation Fase 3 LIBerate-CVD laat 55-60% daling zien in LDL-C. Het is nog onduidelijk wat de meerwaarde is ten opzichte van huidige behandelopties.
Duration of treatment continuous
Frequency of administration 1 times a month
Dosage per administration 300 mg
References NCT04797247 (LIB003-005; LIBerate-CVD)

Expected patient volume per year

References GIPdatabank. 2024 (1).
Additional remarks In 2023 waren er 32.830 gebruikers van de PCSK9-remmers evolocumab en alirocumab. Er waren 1.574 gebruikers van inclisiran (1). De voorlopige verwachting is dat lerodalcibep geen groot deel van de markt gaat overnemen, omdat er nog geen duidelijke meerwaarde is ten opzichte van huidige behandelopties.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.