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Deucravacitinib

Extended indication

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
Therapeutic value

Possible added value for a subgroup
Registration phase

Clinical trials

Product

Active substance

Deucravacitinib
Domain

Chronic immune diseases
Reason of inclusion

New medicine (specialité)
Main indication

Skin diseases
Extended indication

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
Manufacturer

BMS
Mechanism of action

Tyrosine kinase inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Particularity

New therapeutical formulation
ATMP

No
Submission date

October 2022
Expected Registration

January 2023
Orphan drug

No
Registration phase

Clinical trials
Additional comments 
De fabrikant verwacht indiening in oktober 2022 en registratie in januari 2023.

Therapeutic value

Current treatment options

Bijvoorbeeld TNF-alfaremmers en Il12/23 remmers.
Therapeutic value

Possible added value for a subgroup
Substantiation

De veiligheid wordt als erg goed beschreven, vergelijkbaar met placebo. Deucravacitinib zal minder effectief zijn dan de biologicals, maar een meerwaarde hebben voor patiënten waarbij de biological niet aanslaat. Ook is het effectiever dan apremilast.
Frequency of administration

1 times a day
Dosage per administration

6mg
References 
NCT04772079

Expected patient volume per year

Additional comments 
Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er circa 165.000. Als ook milde psoriasis onder de indicatie komt te vallen kan het beschikbaar zijn voor 500.000 patiënten.

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.