Difelikefalin

Active substance Difelikefalin
Domain Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Skin diseases
Extended indication Pruritus In Hemodialysis Patients

Product

Proprietary name Korsuva
Manufacturer Cara
Mechanism of action Receptor agonist
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Opioïd kappa receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation De fase 2 studie genaamd KALM-1 heeft zijn primaire eindpunten gehaald. De fase 3 studie loopt op dit moment nog.
Frequency of administration 3 times a week
Dosage per administration 0,5 µg/kg
References NCT03422653; NCT03636269
Additional comments Toediening na iedere nierdialyse.

Expected patient volume per year

Patient volume

< 2,750

Market share is generally not included unless otherwise stated.

References Nierstichting; Hu et al. Medicine (Baltimore). 2018 May; 97(21): e10633.
Additional comments Ruim 5.000 mensen in Nederland krijgen hemodialyse. De inschattingen van het aantal dialysepatiënten die last hebben van jeuk varieert, maar wordt in de literatuur ingeschat op 55%. Dit zou 2750 mogelijke patiënten in Nederland betekenen. Welk deel van deze patiëntengroep in aanmerking komt voor deze behandeling is nog onduidelijk.

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 Yes
Indication extensions Prutitus CKD stages III-IV; Pruritus CLD; Atopic dermatitis; Acute postoperative pain
References Website Cara Therapeutics

Other information

There is currently no futher information available.