The European Commission (EC) has granted marketing authorization for OBGEMSA™ (vibegron) by Pierre Fabre Laboratories, indicated for the symptomatic treatment of overactive bladder syndrome in adults, a condition impacting over 70 million individuals in Europe. In 2022, Pierre Fabre Laboratories obtained the exclusive license for vibegron from Urovant Sciences GmbH for its registration and commercialization within the European Economic Area. This authorization applies to all European Union member states, as well as Iceland, Liechtenstein, and Norway. OBGEMSA™ is a trademark owned by Urovant Sciences.
"We are thrilled with this development, which enables European patients to access a new therapeutic solution for overactive bladder syndrome and bolsters our over 40 years of expertise in urology. This decision underscores Pierre Fabre Laboratories' commitment to providing innovative therapies that improve the management of chronic debilitating conditions," stated Eric Ducournau, CEO of Pierre Fabre Laboratories.
The EC's decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on April 25. This recommendation is based on outcomes from two critical, multicenter, double-blind, randomized phase 3 studies in adults with overactive bladder symptoms. Study RVT-901-3003 (EMPOWUR) assessed the efficacy, tolerability, and safety of 75 mg daily dose of vibegron over 12 weeks compared to placebo, with tolterodine as a positive control. The subsequent study, RVT-901-3004 (EMPOWUR Extension), evaluated the long-term safety, tolerability, and efficacy of vibegron over 52 weeks, using tolterodine as an active comparator. Vibegron, a novel selective agonist of beta-3 adrenergic receptors (AR), exhibited a favorable benefit-risk profile in treating urgency, increased urination frequency, and urge urinary incontinence (UUI) in patients with overactive bladder syndrome [citation:2][citation:9].