A marketing authorization should be given for the medicinal product Obgemsa (vibegron) for treating adults with overactive bladder (OAB) syndrome, the European Medicines Agency (EMA) has said.
OAB syndrome is characterized by a sudden and intense urge to urinate, even though the bladder may only contain a small amount of urine, as well as increased micturition frequency and urgency incontinence.
The active substance of Obgemsa is vibegron, a urological drug for urinary frequency and incontinence. Vibegron is a selective human beta 3-adrenoceptor (beta 3-AR) agonist. By activating the beta 3-AR in the bladder, vibegron flattens and lengthens the base of the bladder, facilitating urine storage.
At a meeting this week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) accepted evidence that the drug reduced the number of daily micturitions and incontinence episodes in patients with OAB, compared with placebo.
Clinical Trials
Crucial evidence on the effectiveness of vibegron came from the 12-week EMPOWUR phase 3 clinical trial and its 40-week extension arm, which demonstrated sustained efficacy in patients who received the drug for 52 weeks.
Improvements to the emotional and psychological impact that OAB can have on patients were also reported in the trial results.
The most common side effects with Obgemsa were headache, diarrhea, nausea, constipation, urinary tract infection, and an increase in residual urine volume, the CHMP noted.
Obgemsa will be available as 75 mg film-coated tablet.
The EMA’s recommendation will be sent to the European Commission, which will decide whether to grant the marketing authorization to the applicant, Pierre Fabre Medicament.