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Vibegron

Obgemsa

Extended indication Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with O
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Vibegron
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Extended indication Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with Over Active Bladder (OAB) syndrome.
Proprietary name Obgemsa
Manufacturer Urovant
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Beta-3 adrenergic receptor agonist.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration July 2024
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie april 2024

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 remarks De overactieve blaas komt bij 10% van de volwassenen voor. Potentieel voor veel patiënten. NCT03492281 (EMPOWUR)

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks 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.