The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pierre Fabre’s Obgemsa (vibegron) to treat overactive bladder (OAB) syndrome.
Obgemsa is now approved in the UK to treat OAB syndrome symptoms like urgency, high urinary frequency, and urinary incontinence in adults.
The active ingredient in this medicine, vibegron, acts as a bladder muscle relaxant.
The recommended dosage is one 75mg film-coated tablet per day.
The MHRA’s approval is backed by findings from a Phase 3 EMPOWUR trial which assessed Obgemsa over 12 weeks.
The late-stage study evaluated 1,515 patients suffering from OAB syndrome.
Patients were randomly assigned to receive either a daily placebo, vibegron 75mg, or an active control.
According to the results, vibegron effectively treated symptoms of OAB syndrome compared to placebo.
Additionally, it reduced daily urination and episodes of incontinence within two weeks of treatment initiation.
These improvements were sustained throughout the 12-week duration of the trial. Further evidence suggested that the therapeutic effects were maintained even after 52 weeks of treatment.
The MHRA will monitor the safety and effectiveness of vibegron closely, as is standard for all medications.
In April 2024, the France-based Pierre Fabre received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for vibegron in OAB syndrome. Subsequently, in July, the European Commission (EC) granted marketing authorisation.
Vibegron, known as Gemtesa in the US, was approved in December 2020 for treating overactive bladder.
In Japan and South Korea, it was approved in September 2018 and October 2022, respectively, under the name Beova.
Gemtesa is a trademark owned by Urovant Sciences and is registered in the US and other countries. In the US, Gemtesa is marketed by Sumitomo Pharma America.
In 2022, Pierre Fabre obtained an exclusive licence from Urovant Sciences to register and market vibegron within the European Economic Area.
