The European Medicines Agency (EMA) has endorsed the granting of a marketing authorization for the medication Obgemsa (vibegron), aimed at treating adults grappling with overactive bladder (OAB) syndrome.
OAB syndrome manifests as a sudden and intense urge to urinate, even when the bladder contains only a small amount of urine, coupled with heightened frequency of urination and instances of urgency incontinence.
Obgemsa’s active ingredient is vibegron, a pharmaceutical designed for addressing urinary frequency and incontinence issues. Vibegron operates as a selective human beta 3-adrenoceptor (beta 3-AR) agonist. By stimulating the beta 3-AR in the bladder, vibegron works to stabilize and elongate the bladder’s base, thus aiding in urine retention.
During its recent session, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed evidence showcasing the drug’s efficacy in reducing daily instances of urination and incontinence episodes among OAB patients, as compared to a placebo.
Clinical Trials Key evidence supporting vibegron’s effectiveness stemmed from the 12-week EMPOWUR phase 3 clinical trial, along with its 40-week extension arm, which highlighted the medication’s sustained efficacy over a 52-week treatment period. Additionally, trial findings indicated enhancements in the emotional and psychological well-being of OAB patients.
As noted by the CHMP, common side effects associated with Obgemsa included headache, diarrhea, nausea, constipation, urinary tract infection, and an increase in residual urine volume.
Obgemsa will be made available in the form of 75 mg film-coated tablets.
The EMA’s recommendation will now be forwarded to the European Commission for a final decision on granting marketing authorization to the applicant, Pierre Fabre Medicament.
- : public
