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Levoketoconazole

Recorlev

Extended indication Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patie
Therapeutic value No estimate possible yet
Total cost 1,650,000.00
Registration phase Clinical trials

Product

Active substance Levoketoconazole
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Metabolic diseases
Extended indication Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery
Proprietary name Recorlev
Manufacturer Strongbridge
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks (2S,4R)-ketoconazole steroïdogeneseremmer

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Twee fase 3 studies hebben hun primary completion date gehad in april 2018 en mei 2019. In maart 2021 ingediend bij de FDA.

Therapeutic value

Current treatment options Pasireotide, ketoconazol, mitotane, metyrapone, mifeproston.
Therapeutic value No estimate possible yet
Substantiation Mogelijk minder bijwerkingen dan bij een behandeling met ketoconazol. Zal met name gebruikt worden als bridging therapie na radiotherapie.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 1200 mg
References NCT01838551; NCT03277690; Scrip, 13 augustus 2018
Additional remarks SONICS trial met efficacy primary endpoint and is well tolerated.

Expected patient volume per year

Patient volume

20 - 100

Market share is generally not included unless otherwise stated.
References Nederlandse Hypofyse Stichting
Additional remarks Naar schatting wordt deze diagnose in Nederland bij ongeveer 50 mensen per jaar gesteld. Levoketoconazole zal de markt moeten delen met pasireotide en mogelijk osilodrostat. Geschat marktaandeel bedraagt 40%. Echter bij Cushing's syndroom mogelijk 60-100 patiënten. Exact aantal patiënten is dus afhankelijk van de precieze indicatiestelling.

Expected cost per patient per year

Cost 20,000.00 - 35,000.00
References GIPdatabank; fabrikant osilodrostat (Novartis)
Additional remarks Pasireotide en osilodrostat zijn geprijsd in de range €20.000-€35.000. Afhankelijk van de therapeutische waarde zal levoketoconazole vergelijkbaar zijn.

Potential total cost per year

Total cost

1,650,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.