The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 17 July 2024, approved the medicine vibegron (Obgemsa)
to treat the symptoms of overactive bladder (OAB) syndrome in
adults. Symptoms may include a sudden need to empty the bladder
(urgency), urinating more frequently (urinary frequency), and
urinary incontinence.
The medicine's active ingredient, vibegron, is a bladder muscle
relaxant (a beta‑3 adrenergic receptor agonist) which reduces the
activity of an overactive bladder and treats the related
symptoms. The recommended dosage for this is 1 tablet per
day. This medicine is prescribed as a 75 mg film‑coated
tablet.
This approval is supported by evidence from a phase 3 clinical
trial. The EMPOWUR trial was used to evaluate vibegron over a
period of 12 weeks in 1,515 patients with OAB syndrome and
demonstrated symptoms of urgency and urinary frequency, with or
without urge urinary incontinence. Patients received a single
daily dose of placebo (n=540), vibegron 75 mg (n=545), or
active control (n=430).
The results showed that compared to the placebo, vibegron was
effective in treating symptoms of OAB syndrome. Daily urination
and incidents of incontinence were reduced in patients with OAB
syndrome. This was observed within two weeks of the trial and was
shown to be constant throughout the 12-week period of treatment.
The outcomes of the study suggested that the effects of the
medicine are maintained after 52 weeks of treatment.
The most common side effects of this medicine include headache,
diarrhoea, constipation, nausea, urinary tract infection, and an
increase in the amount of urine left in the bladder after
voluntary urination.
As with any medicine, the MHRA will keep the safety and
effectiveness of vibegron under close review. Anyone who
suspects they are having a side effect from this medicine are
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the Yellow Card scheme, either through the
website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
- The new marketing authorisation for vibegron (Obgemsa) was
granted on 17 July 2024 to Pierre Fabre Limited.
- More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will be
published on the MHRA Products
website within 7 days of approval.
