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KX2-391

Extended indication Keratosis actinica
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance KX2-391
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Keratosis actinica
Manufacturer Athenex
Route of administration Cutaneous
Therapeutical formulation Ointment
Budgetting framework Extramural (GVS)
Additional remarks Mechanism of action: "Angiogenesis inhibitors; Interleukin 2 inhibitors; Keratinocyte inhibitors; Src-Family kinase inhibitors; Tubulin polymerisation inhibitors."

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Scrio: "AK003, AK004; achieved primary endpoint."

Therapeutic value

Current treatment options Cryotherapie, Efudix crème (actieve stof: 5-fluorouracil), Aldara crème (actieve stof: imiquimod 5%), Zyclara creme (actieve stof: imiquimod 3.75%), Picato gel (actieve stof: ingenol-mebutaat), PhotoDynamische Therapie (PDT) (daglicht / conventioneel), curettage (wegschrapen of uitlepelen), chemische peeling, fractionele CO2 laser.
Therapeutic value No judgement
Substantiation meerwaarde nog onbekend
Frequency of administration 1 times a day
References NCT03285490, NCT03285477. NVDV richtlijn, update richtlijn actinische keratosen 2017.

Expected patient volume per year

Patient volume

< 112,500

Market share is generally not included unless otherwise stated.
References Richtlijn, Actinische keratose.
Additional remarks De prevalentie actinische keratosen in Nederland betreft 50% van de mannen die 70 jaar of ouder zijn, en 30% van de vrouwen die 70 jaar of ouder zijn (resp. 471.360 en 360.390). De incidentie van actinische keratosen in Nederland is in het CFH-rapport van Metvix® uit 2005 geschat op circa 112.500 patiënten per jaar. Gezien er veel behandelopties zijn zal het aantal patiënten dat in aanmerking komt afhankelijk zijn van de meerwaarde ten opzichte van deze 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

Indication extension No
Additional remarks Geen andere fase III studies.

Other information

There is currently no futher information available.