Vibegron

Active substance Vibegron
Domain Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Extended indication Overactive bladder

Product

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 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Fase 3 Empowur studie resultaten: https://www.businesswire.com/news/home/20200302005268/en/Urovant-Sciences-Announces-Publication-Phase-3-EMPOWUR.

Therapeutic value

Current treatment options Urologische spasmolytica
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 75 mg
References Farmakotherapeutisch kompas; NCT03492281

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

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

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.