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

1. 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

2. Registration

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

3. 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.

4. 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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.