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MHRA approves Pierre Fabre’s vibegron to treat OAB
18 Jul 2024
Clinical ResultPhase 3Drug Approval
The asset is indicated for the treatment of overactive bladder syndrome symptoms in adult patients. Credit: New Africa / Shutterstock.
The UK Medicines and Healthcare products Regoveractive bladder syndromepproved Pierre Fabre’s vibegron (Obgemsa) to treat overactive bladder (OAB) syndrome symptoms in adults.
Symptoms include urgency, high urinary frequency and incontinence.vibegronObgemsaoveractive bladder (OAB) syndrome
A beta 3 adrenergic receptor agonist, vibegron functiincontinencedder muscle relaxant to ease the bladder muscle activity.
Thbeta 3 adrenergic receptor agonistbeta 3 adrenergic receptors a 75mg fvibegroned tablet.
The approval is backed by data from the Phase III EMPOWUR clinical trial, which assessed it for 12 weeks in 1,515 OAB patients.
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Participants received a daily dose of either placebo, vibegron 75mg or an active control.
Modernan significantly reduced daily urination and incontinence episodes versus placebo, with improvements observed within two weeks and sustained over the treatment period.
Patients on vibegron reported side effects such as headaches, diarrhoea, constipation, nausea, urinary tract infections and increased post-void residual urine volume.
The MHRA assures ongoing monitoring of vibegron’s safevibegronfficacy and encourages reporting of any side effects through the Yellow Card scheme.
Vibegron has also approved AstraZeneca’s capivasertincontinencefor advanced HR-positive, HER2-negative breast cancer with specific genetic abnormalities unresponsive to other treatments.
Capivasertibvibegron inhibitor, impedes cancer cellheadachesatdiarrhoeas constipation onauseaalurinary tract infectionsormonal therapy.
The approval was supported by a clinicavibegroninvolving 708 patients, with a subset of 289 patients exhibiting the targeted genetic mutations.
In cMHRAcal studies, capivaAstraZenecatedcapivasertib (Truqap)veragadvanced HR-positivengHER2-negative breast cancer progress, compared to 3.1 months for placebo-treated patients.
Capivasertibugar,AKTarrhoea, rash and otcancerin drug responses, urinary tract infection, low blood haefulvestrantvels, appetite loss, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching and fatigue are possible side effects of the medication.
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