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Teprasiran

Extended indication Renal transplant, prevention of delayed graft function in recipients of a deceased older donor kidney
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Teprasiran
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Other chronic immune diseases
Extended indication Renal transplant, prevention of delayed graft function in recipients of a deceased older donor kidney
Manufacturer Quark
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks QPI1002 is een siRNA oligonucleotide gericht tegen p53. Novartis heeft de rechten voor de commercialisatie.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion date van de ReGIFT studie is in juni 2019.

Therapeutic value

Current treatment options Verschillende immunosuppressiva (o.a. antilichamen zoals basiliximab en antithymocyte immunoglobulin, calcineurin inhibitors zoals ciclosporin of tacrolimus, azathioprine, mycophenolate mofetil en corticosteroïden zoals prednisolone of methylprednisolone).
Therapeutic value No judgement
Duration of treatment one-off
References NCT02610296

Expected patient volume per year

Patient volume

90 - 150

Market share is generally not included unless otherwise stated.
References Nierstichting.nl; quarkpharma
Additional remarks In 2017 vonden er 425 niertransplantaties plaats met een nier van een overleden donor. Volgens de fabrikant komt delayed graft function voor bij 21-35% van de gevallen. Voor Nederland zou dit dan bij 89-149 patiënten voorkomen. Het aantal patiënten wat daadwerkelijk in aanmerking komt is afhankelijk van de therapeutische waarde en de plaats in de behandelrichtlijn.

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 Acute kidney injury, fase II
References clinicaltrials.gov; quarkpharma.com

Other information

There is currently no futher information available.