UK MHRA Grants Marketing Authorization to Pierre Fabre’s Vibegron

UK MHRA Grants Marketing Authorization to Pierre Fabre’s Vibegron

By, Admin 22 July 2024

UK MHRA grants marketing authorization to Pierre Fabre’s vibegron to treat overactive bladder syndrome

Overview

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has 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 new marketing authorisation for vibegron (Obgemsa) was granted on 17th July, 2024 to Pierre Fabre Limited.

About Vibegron

  • 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.

The EMPOWUR Trial

  • 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.

Common Side Effects

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.

Safety Review by MHRA

  • 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.

The MHRA is an executive agency of the Department of Health and Social Care.

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