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Difelikefalin

Korsuva

Extended indication Pruritus In Hemodialysis Patients
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Difelikefalin
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Pruritus In Hemodialysis Patients
Proprietary name Korsuva
Manufacturer Cara
Mechanism of action Receptor agonist
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Opioïd kappa receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registration application pending
Additional remarks SPS UK: "Mar 21 · Filed in Europe via centralised procedure; a regulatory decision is expected second quarter of 2022"

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase 3 studie genaamd KALM-2 heeft zijn primaire eindpunten op basis van de (WI-NRS) schaal gehaald.
Duration of treatment continuous
Frequency of administration 3 times a week
Dosage per administration 0,5 µg/kg
References NCT03422653; NCT03636269
Additional remarks 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 remarks 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 2.750 mogelijke patiënten in Nederland betekenen.

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 3-4; Pruritus CLD; Atopic dermatitis; Acute postoperative pain
References Website Cara Therapeutics

Other information

There is currently no futher information available.