Extended indication Overactive bladder
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Vibegron
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Extended indication Overactive bladder
Manufacturer Urovant
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Beta-3 adrenergic receptor agonist.

Registration

Registration route Centralised (EMA)
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials
Additional comments NCT03492281 (EMPOWUR)

Therapeutic value

Current treatment options Urologische spasmolytica, bijvoorbeeld mirabegron.
Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 75 mg
References Farmakotherapeutisch kompas; NCT03492281 (EMPOWUR)

Expected patient volume per year

References Kenniscentrum Urologie Slingeland Ziekenhuis
Additional comments De overactieve blaas komt bij 10% van de volwassenen voor. Potentieel voor veel patiënten.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments De prijs in Nederland is nog niet bekend. Kosten voor bijvoorbeeld mirabegron dat op dit moment voor deze indicatie wordt gebruikt bedragen ongeveer €0,82 per dag. Dit betekent €300 per patiënt per jaar.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use Yes
Indications off label use Fase 2: OAB in Men with Benign Prostatic Hyperplasia (BPH), fase 1: irritable bowel syndrome (IBS) associated pain.
References Urovant.com

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.