Posted by Michael Wonder on 23 May 2023
Pierre Fabre announces start of EU marketing authorization application procedure for vibegron in overactive bladder
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the EU marketing authorisation application procedure (centralised procedure) for vibegron, a novel, potent, and selective human β3 adrenergic receptor agonist inducing muscle relaxation to increase bladder capacity and relieve symptoms of overactive bladder.
The submission is based on positive data from the pivotal, randomised, double-blind, and active (tolterodine)-controlled multicenter Phase 3 studies in patients with symptoms of overactive bladder, Study RVT-901-3003, which assessed the efficacy, tolerability and safety of vibegron (at a dose of 75 mg) and its extension, Study RVT-901-3004, which assessed the long-term safety, tolerability and efficacy of vibegron.
