European Commission approves Obgemsa (vibegron) for the symptomatic treatment of overactive bladder syndrome in adults
The European Commission (EC) has authorized the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients* in Europe
In 2022, Pierre Fabre Laboratories acquired the exclusive license for vibegron from Urovant Sciences Gmbh for the registration and commercialization of this innovative treatment in the European Economic Area. The decision of the EC will be applicable to all EU member states as well as Iceland, Liechtenstein, and Norway. Obgemsa is a trademark owned by Urovant Sciences.
The decision is based on the results of two pivotal, multicenter, double-blind, randomized phase III studies in adults with overactive bladder symptoms. Study RVT-901-3003 (EMPOWUR) evaluated the efficacy, tolerability, and safety of vibegron (at a dose of 75 mg per day) over 12 weeks compared to placebo and with tolterodine as a positive control. Its extension, study RVT-901-3004 (EMPOWUR Extension), double-blindly evaluated the long-term safety, tolerability, and efficacy of vibegron over 52 weeks, with tolterodine as an active comparator. In these studies, vibegron, as a new selective agonist of beta-3 adrenergic receptors (AR), demonstrated a favorable benefit-risk profile in the symptomatic treatment of urgency, increased frequency of urination, and urge urinary incontinence (UUI) that can occur in patients with overactive bladder syndrome.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins