Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA™ (vibegron) in overactive bladder.

The decision of the EC follows the favorable opinion issued on April 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It is based on the results of two pivotal, multicenter, double-blind, randomized phase 3 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…

France, 28/06/2024 (informazione.it - comunicati stampa - salute e benessere)

The decision of the EC follows the favorable opinion issued on April 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It is based on the results of two pivotal, multicenter, double-blind, randomized phase 3 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.

Contact:

Laurence MARCHAL
laurence.marchal@pierre-fabre.com  

PDF - https://mma.prnewswire.com/media/2451098/Pierre_Fabre.pdf

 

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